Identity
- Trade Name
- PiSA BioPharm FDA UDI
- Generic Name
- Intravenous administration bag/bottle FDA UDI
- Device Name
- Empty EVA Bag 500 mL FDA UDI
- Model / Reference
- 60003 FDA UDI
- Description
- Empty EVA Bag 500 mL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850002046182 FDA UDI
- FDA Product Code
- KPE FDA UDI
- GMDN Term
- Intravenous administration bag/bottle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5025 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Category: Intravenous administration bag/bottle
PiSA BioPharm by Pisa Biopharm Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intravenous administration bag/bottle.
- Bag for enzyme replacement therapy — VALMED SRL · Class IIa
- Parenteral nutrition bag — VALMED SRL · Class IIa
- Parenteral nutrition bag — VALMED SRL · Class IIa
- Parenteral nutrition bag — VALMED SRL · Class IIa
- Parenteral nutrition bag — VALMED SRL · Class IIa
- SECURE® — METRIX COMPANY, THE · Class II
- Empty Fluid Container 250 ml Max Capacity (NFV Fill Port with Seal-Tab) — Epic International (Thailand) Co., Ltd. · Class I
- EVA TPN Bags — Valmed Corp. · Class II
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
- Pisa Biopharm Inc.
Sources (1)
- FDA UDI 6e297ce8-5bef-464e-971d-25aa24ebc58d 34 fields · synced May 30, 2026