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Breathing bag 1.5L ISO-silicone
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 2166127Model 208044PK19T010
Identity
- Trade Name
- Atembeutel 1.5 L, Silikon EUDAMEDBreathing bag 1.5L ISO-silicone FDA UDI
- Generic Name
- Breathing circuit bag, reusable FDA UDI
- Model / Reference
- 2166127 EUDAMEDFDA UDI208044PK19T010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675023494 EUDAMEDFDA UDI
- Basic UDI-DI
- 040486751208044PK19T0109Z EUDAMED
- Direct Marketing DI
- 04048675023494 EUDAMED
- FDA Product Code
- BTC FDA UDI
- EMDN Code
- R03020101 ANAESTHESIA BALLOONS EUDAMED
- GMDN Term
- Breathing circuit bag, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5320 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Breathing circuit bag, reusable
Breathing bag 1.5L ISO-silicone by Drägerwerk AG & Co. KGaA — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Drägerwerk AG & Co. KGaA
Sources (2)
- FDA UDI a38acb47-f12b-4662-a04e-0f322684d60a 33 fields · synced Aug 1, 2026
- EUDAMED cab1a570-6906-40a3-8bf4-0f460e1442da 61 fields · synced Jul 28, 2026