Identity
- Trade Name
- Large Volume Paracentesis Kit FDA UDI
- Generic Name
- Pleurocentesis/paracentesis kit FDA UDI
- Device Name
- The GI Supply Large Volume Paracentesis Kit FDA UDI
- Model / Reference
- GIS-28 FDA UDI
- Description
- The GI Supply Large Volume Paracentesis Kit FDA UDI
Identifiers
- Catalog Number
- GIS-28 FDA UDI
- Primary DI / UDI-DI
- 00893029002007 FDA UDI
- 510(k) Number
- K970187 FDA UDI
- FDA Product Code
- LRO FDA UDI
- GMDN Term
- Pleurocentesis/paracentesis kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 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
Yes
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
No
FDA UDI
Large Volume Paracentesis Kit by GI Supply, Inc. — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GI Supply, Inc.
Sources (1)
- FDA UDI e90af11a-1fc1-4e93-8a79-75ad64feaa5c 38 fields · synced May 31, 2026