Identity
- Trade Name
- KC 003N-2P 3-liter reservoir bag FDA UDI
- Generic Name
- Breathing circuit bag, single-use FDA UDI
- Device Name
- The KC 003N-2P is a 3-liter neoprene reservoir bag intended to store breathing gas during the respiratory cycle. The breathing bag may be on the inspiratory or expiratory limb of a breathing circuit depending on the breathing circuit design. This is a single-use device. FDA UDI
- Model / Reference
- KC 003N-2P FDA UDI
- Description
- The KC 003N-2P is a 3-liter neoprene reservoir bag intended to store breathing gas during the respiratory cycle. The breathing bag may be on the inspiratory or expiratory limb of a breathing circuit depending on the breathing circuit design. This is a single-use device. FDA UDI
Identifiers
- Catalog Number
- KC 003N-2P FDA UDI
- Primary DI / UDI-DI
- M996KC003N2P0 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Breathing circuit bag, single-use
KC 003N-2P 3-liter reservoir bag by Instrumentation Industries, Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Instrumentation Industries, Incorporated
Sources (1)
- FDA UDI ad1cdc4c-4a5e-4ef6-ad08-553f17e99e7a 35 fields · synced May 30, 2026