Identity
- Trade Name
- Disposable breathing circuit, 1.70m FDA UDI
- Generic Name
- Anaesthesia breathing circuit, single-use FDA UDI
- Model / Reference
- 28110 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04054685129996 FDA UDI
- 510(k) Number
- K193191 FDA UDI
- FDA Product Code
- BTL FDA UDI
- GMDN Term
- Anaesthesia breathing circuit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5925 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Anaesthesia breathing circuit, single-use
Disposable breathing circuit, 1.70m by Weinmann Emergency Medical Technology GmbH + Co. KG — Class II — FDA UDI — listed in FDA GUDID
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Cleared under the same submission
K193191 also covers:
- Low-pressurehose assembly, 2m, 02 green DISS/ CHEMETRON — Weinmann Emergency Medical Technology GmbH + Co. KG
- Low-pressurehose assembly, 2m, 02 green DISS/ DISS — Weinmann Emergency Medical Technology GmbH + Co. KG
- Low-pressurehose assembly, 2m, 02 green DISS/ OHMEDA — Weinmann Emergency Medical Technology GmbH + Co. KG
- Low-pressurehose assembly, 2m, 02 green DISS/ PURITAN BENNET — Weinmann Emergency Medical Technology GmbH + Co. KG
- MEDUMAT Easy CPR — Weinmann Emergency Medical Technology GmbH + Co. KG
- MEDUtrigger — Weinmann Emergency Medical Technology GmbH + Co. KG
- MEDUtrigger — Weinmann Emergency Medical Technology GmbH + Co. KG
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
- Weinmann Emergency Medical Technology GmbH + Co. KG
Sources (1)
- FDA UDI e88ee308-e036-4985-aacf-ef7da81952de 33 fields · synced May 30, 2026