Identity
- Trade Name
- PEDIA FDA UDI
- Generic Name
- Breathing circuit bag, single-use FDA UDI
- Model / Reference
- P001P FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860003582725 FDA UDI
- 510(k) Number
- K181424 FDA UDI
- FDA Product Code
- BTC FDA UDI
- GMDN Term
- Breathing circuit bag, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5320 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Breathing circuit bag, single-use
Pedia by Pedia — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Breathing circuit bag, single-use.
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- 2 LITER CONTOUR® — KING SYSTEMS CORPORATION. · Class I
- Halyard Breathing Bag — Airlife, Inc. · Class I
- Breathing bags — Shandong Jinlai Huanhai Medical Technology Co., Ltd. · Class I
- Breathing bags — Shandong Jinlai Huanhai Medical Technology Co., Ltd. · Class I
- Breathing bag anest disp 1L compl — Maquet Critical Care AB · Class I
Cleared under the same submission
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 |
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Manufacturer
- Manufacturer
- Pedia
Sources (1)
- FDA UDI e065e883-08e2-4150-b139-b4a3d6f90d97 34 fields · synced May 30, 2026