Identity
- Trade Name
- BREEZE® APD FDA UDI
- Generic Name
- Abdominal paracentesis needle, single-use FDA UDI
- Device Name
- 16F X 35CM BREEZE® ALL PURPOSE DRAIN WITH LOCKING PIGTAIL SET FDA UDI
- Model / Reference
- BALPN1635S FDA UDI
- Description
- 16F X 35CM BREEZE® ALL PURPOSE DRAIN WITH LOCKING PIGTAIL SET FDA UDI
Identifiers
- Catalog Number
- BALPN1635S FDA UDI
- Primary DI / UDI-DI
- 00884908138825 FDA UDI
- FDA Product Code
- FGE FDA UDI
- GMDN Term
- Abdominal paracentesis needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5010 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
Yes
FDA UDI
Breeze® Apd by Medical Components 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 |
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Manufacturer
- Manufacturer
- Medical Components Inc
Sources (1)
- FDA UDI b874f845-e6ec-4931-80bb-59eadc678f36 36 fields · synced May 30, 2026