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Tubing, 6 ft (1.83m), High-Temp
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1007800Model Breathing Circuit Accessories
Identity
- Trade Name
- Tubing, 6 ft (1.83m), High-Temp EUDAMEDTubing FDA UDI
- Generic Name
- Ventilator breathing circuit, reusable FDA UDI
- Device Name
- Tubing, 6ft, High-Temp FDA UDI
- Model / Reference
- Breathing Circuit Accessories EUDAMED1007800 EUDAMED00 FDA UDI
- Description
- Tubing, 6ft, High-Temp FDA UDI
Identifiers
- Catalog Number
- 1007800 FDA UDI
- Primary DI / UDI-DI
- 00606959020337 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959020337 EUDAMED
- FDA Product Code
- BYX FDA UDI
- EMDN Code
- R02010402 NIV CIRCUITS EUDAMED
- GMDN Term
- Ventilator breathing circuit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5860 FDA UDI
- Market of Registration
- Austria 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Tubing, 6 ft (1.83m), High-Temp by Respironics Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-00606959020337 | 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 a5ecfc01-145a-4bfa-93d1-a35693f7d426 61 fields · synced Jul 26, 2026
- FDA UDI 5833acd0-df22-40f6-a880-35c06e049f2c 36 fields · synced May 22, 2026