Identity
- Trade Name
- INSUFLOW FDA UDI
- Generic Name
- Insufflation gas conditioning tubing set FDA UDI
- Device Name
- LAPAROSCOPIC GAS CONDITIONING DEVICE FDA UDI
- Model / Reference
- 6198M FDA UDI
- Description
- LAPAROSCOPIC GAS CONDITIONING DEVICE FDA UDI
Identifiers
- Catalog Number
- 6198M FDA UDI
- Primary DI / UDI-DI
- 00852588007038 FDA UDI
- FDA Product Code
- HIF FDA UDI
- GMDN Term
- Insufflation gas conditioning tubing set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1730 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Insuflow by Lexion Medical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Lexion Medical LLC
Sources (1)
- FDA UDI f238a0d0-bc97-4493-b1cc-38f8393383a0 35 fields · synced Jun 8, 2026