Identity
- Trade Name
- Disposable Infusion Bag for Parenteral Nutrition FDA UDI
- Generic Name
- Intravenous administration bag/bottle FDA UDI
- Device Name
- The proposed device is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. The proposed device is provided sterile and single use. FDA UDI
- Model / Reference
- BEDX FDA UDI
- Description
- The proposed device is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. The proposed device is provided sterile and single use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945326839542 FDA UDI
- FDA Product Code
- KEP FDA UDI
- GMDN Term
- Intravenous administration bag/bottle FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4010 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
No
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
Category: Intravenous administration bag/bottle
Disposable Infusion Bag for Parenteral Nutrition by Beijing L&Z Medical Technology Development Co., Ltd — Class I — FDA UDI — listed in FDA GUDID
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beijing L&Z Medical Technology Development Co., Ltd
Sources (1)
- FDA UDI cc50548e-5f05-46e9-962f-08a318c11dca 33 fields · synced May 30, 2026