CDSCO UID IMP/MD/2021/000430_7a9c470d6ba00dce4d961d9650ef3eec_0eef72b2648cb974a3244aa144d22b63

Hemoperfusion cartridge

Baxter India Private Limited·Device Class Class C·India CDSCO·Brand: U9000 PLUS
Registration details
UID
IMP/MD/2021/000430_7a9c470d6ba00dce4d961d9650ef3eec_0eef72b2648cb974a3244aa144d22b63
Device class
Class C
Brand name
U9000 PLUS
Approving authority
CDSCO
Product information
Hemoperfusion should be considered if: 1. After taking life threatening amounts of adsorbable drugs, deep coma and one of the following symptoms are observed: • hypoventilation • hypotonia • hypothermia • worsening of the clinical state despite conservative medical management; 2. the patient has taken drugs of which the amount, composition and kind are unknown and the patient is deeply comatose. The Adsorba has proven a high degree of efficacy for the following drugs: • barbiturates • organophosphates • bromocarbamide • paracetamol • ethchlorvynol • paraquat • meprobamate • phenacetin • methaqualone • salicylate The use of hemoperfusion as a supplementary treatment does not mean that other conventional methods of treatment should be omitted; measures such as gastric lavage, establishment of free airway and assisted respiration, controlled electrolyte and water balance, and forced diuresis should be administered whenever indicated. Futhermore it might be necessary to monitor carefully the blood levels of vital substances or drugs which also could be adsorbed during the hemoperfusion treatment. Access to the blood stream for hemoperfusion treatment can be obtained by normal hemodialysis methods
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About this record

Hemoperfusion cartridge is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000430_7a9c470d6ba00dce4d961d9650ef3eec_0eef72b2648cb974a3244aa144d22b63. This device is marketed under the brand name U9000 PLUS. The license holder is Baxter India Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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