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Disposable Perfusion Sets - India CDSCO Medical Device Registration

Disposable Perfusion Sets is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000029_3baa9be253f8dbeed4b1b9635caa2048_017b6e6e641043d1e9cbdc8b8b6381b6. This device is marketed under the brand name Disposables for injectorsulricheasyINJECT XD 10xxx. The license holder is Anaecon India Healthcare Pvt. Ltd. ,E-57, Phase-1, Sector A-7, Tronica Industrial Area, Signature City, Ghaziabad, U.P. ,Ghaziabad Uttar Pradesh ,201103 ,India, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered
Class Class C
Disposable Perfusion Sets
UID: IMP/MD/2020/000029_3baa9be253f8dbeed4b1b9635caa2048_017b6e6e641043d1e9cbdc8b8b6381b6

Brand Name

Disposables for injectorsulricheasyINJECT XD 10xxx

Device Class

Class C

Approving Authority

CDSCO

Product Information

Patient hose XD 2030, XD 2035, XD 2040, XD 2045: The patient hose for ulrich medical CT/MRI injectors is intended for the venous administration of contrast media and physiological saline solutions (Disposables for injectorsulricheasyINJECT XD 10xxx) during a CT/MRI examination. The patient hose creates the connection from the ulrich medical pump hose (Disposables for injectorsulricheasyINJECT XD 10xxx) to the patient. // Pump hose XD 2020for ulrich medical CT/MRI injectors: The pump hose for ulrich medical CT/MRI injectors is intended for the venous administration of contrast media and physiological saline solution (Disposables for injectorsulricheasyINJECT XD 10xxx) during a CT/MRI examination. The pump hose connects the injector (Disposables for injectorsulricheasyINJECT XD 10xxx) to the patient hose. The pump hose can be used for any number of injections within a 24hour period. // Pump hose XD 8003 for ulrich medical CT/MRI injectors: The pump tubing for ulrich medical CT/MRI injectors is intended for the venous administration of contrast media and physiological saline solution (Disposables for injectorsulricheasyINJECT XD 10xxx) during a CT/MRI examination. The pump tubing connects the injector (Disposables for injectorsulricheasyINJECT XD 10xxx) to the patient tubing. The pump tubing can be used for any number of injections within a24hour period. // Reservoir for contrast media: (Disposables for injectorsulricheasyINJECT XD 10xxx): The reservoir ensures the compatibility of the pump tubing with media containers that have a Luer lock connector, and with small bottles, and is exclusively intended for use with ulrich contrast media injectors. The reservoir is connected by means of the pump tubingโ€™s spike to the place provided for that purpose, in order to then completely decant the contents of the media container into the reservoir one time.The reservoir is designed to be used for a maximum of 24 hours, and for any desired number of injections. It is not intended to be re-used or re-sterilized. Plugging the pump tubingโ€™s spike in multiple times is prohibited. In addition to CT and MRI contrast media, the reservoir can also be filled with isotonic saline solution. Mixingnon isotonic saline solution in the reservoir is not allowed. This product contains the plasticizer DEHP. Handling by children, pregnant women or breastfeeding women is therefore prohibited. The reservoir must only be used by qualifed and medically trained personnel. The intended purpose for ulrich contrast media injectors remains in effect without changes, and is extended by the intended purpose for the reservoir for contrast media.

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Other Products from Anaecon India Healthcare Pvt. Ltd. ,E-57, Phase-1, Sector A-7, Tronica Industrial Area, Signature City, Ghaziabad, U.P. ,Ghaziabad Uttar Pradesh ,201103 ,India
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