CDSCO UID IMP/MD/2020/000273_eceec8ac26398703a576013ab582db56_da75cca4f6fc6b4f83cd9d26b4dab241
Epidural Catheters
SMITHS MEDICAL INDIA PRIVATE LIMITED ,GALA 4B,5B,6B,7, 8, 9 & 10, GR FL, BLDG E-3, SHREE KALKI LOG SHREE RAJLAXMI LOGISTICS PARK, OLD BHIWANDI-AGRA ROAD, DHAMANGAON - 421302, Taluka BHIWANDI - 16, District THANE Z5 ,Thane Maharashtra ,421302 ,India·Device Class Class B·India CDSCO·Brand: Portex
Registration details
- UID
- IMP/MD/2020/000273_eceec8ac26398703a576013ab582db56_da75cca4f6fc6b4f83cd9d26b4dab241
- Device class
- Class B
- Brand name
- Portex
- Approving authority
- CDSCO
- Product information
- A range of sterile, single use packs containing a variety of components for the placement of an epidural catheter into the epidural space to allow bolus injections or continuous infusion of local anaesthetic or other drugs for pain relief. The range is available with a choice of colour coded 16G and 18G epidural needles, clear or radioopaque, closed end, 3-lateral eye and Closer Three Eye (Portex) or open end formed Nylon epidural catheters. Consult product literature for details/code numbers. The Paediatric 18G Minipack System 1 (Portex) contains a Paediatric length (Portex) graduated Epidural Tuohy Needle and 18G Epidural Catheter (Portex). The Minipack System 1 (Portex) contains an extra length Epidural Tuohy Needle (Portex). The 16G and 18G Epidural Catheters in System 3 packs are intended for introduction through 16G and 18G Epidural Tuohy Needles respectively
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About this record
Epidural Catheters is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000273_eceec8ac26398703a576013ab582db56_da75cca4f6fc6b4f83cd9d26b4dab241. This device is marketed under the brand name Portex. The license holder is SMITHS MEDICAL INDIA PRIVATE LIMITED ,GALA 4B,5B,6B,7, 8, 9 & 10, GR FL, BLDG E-3, SHREE KALKI LOG SHREE RAJLAXMI LOGISTICS PARK, OLD BHIWANDI-AGRA ROAD, DHAMANGAON - 421302, Taluka BHIWANDI - 16, District THANE Z5 ,Thane Maharashtra ,421302 ,India, and it is classified as Device Class Class B. The approving authority is CDSCO.
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