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(10) BiPAP Disposable Humidifier Tubing 36 IN (91cm)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 312111
Identity
- Trade Name
- (10) BiPAP Disposable Humidifier Tubing 36 IN (91cm) EUDAMEDBiPAP FDA UDI
- Generic Name
- Ventilator breathing circuit, single-use FDA UDI
- Device Name
- BiPAP Disp Circuits EUDAMEDBiPAP Disposable Humidifier Tubing, 36 inch, box of 10 FDA UDI
- Model / Reference
- 312111 EUDAMEDFDA UDI
- Description
- BiPAP Disposable Humidifier Tubing, 36 inch, box of 10 FDA UDI
Identifiers
- Catalog Number
- 312111 FDA UDI
- Primary DI / UDI-DI
- 00606959002616 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959002616 EUDAMED
- FDA Product Code
- MNT FDA UDI
- EMDN Code
- Z12030104 PORTABLE PULMONARY VENTILATORS EUDAMED
- GMDN Term
- Ventilator breathing circuit, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 36 Inch FDA UDI
(10) BiPAP Disposable Humidifier Tubing 36 IN (91cm) by Respironics, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00606959002616 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (2)
- EUDAMED 53feeb26-3eab-4ad9-8faf-b5a917c011f0 61 fields · synced Jun 17, 2026
- FDA UDI 73363c31-a8c6-40b1-bf14-9f410d3de33d 37 fields · synced May 30, 2026