Identity
- Trade Name
- In-Line Gas Warmer FDA UDI
- Generic Name
- Insufflation gas conditioning system control unit FDA UDI
- Device Name
- In-Line gas warmer is for use with laparoscopic insufflators FDA UDI
- Model / Reference
- 72-00204-0 FDA UDI
- Description
- In-Line gas warmer is for use with laparoscopic insufflators FDA UDI
Identifiers
- Catalog Number
- 7209944 FDA UDI
- Primary DI / UDI-DI
- 00817183020592 FDA UDI
- 510(k) Number
- K992381 FDA UDI
- FDA Product Code
- HIF FDA UDI
- GMDN Term
- Insufflation gas conditioning system control unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1730 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Insufflation gas conditioning system control unit
In-Line Gas Warmer by Northgate Technologies Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K992381 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Northgate Technologies Inc.
Sources (1)
- FDA UDI 9218d734-1171-4c27-b134-e247045c4110 35 fields · synced May 30, 2026