Gas Sampling line, (Female/ Female)
by Besmed Health Business Corp. Taiwan EUDAMEDGUDID
Ref OT-83320 Product code CCKEMDN R03010207
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-OT-833208R | Date4 May 2022 | StatusActive |
| United States | GUDID listing GUDID | NumberD-OT-833208R | Date7 Sep 2016 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Trade Name
- Gas Sampling line, (Female/ Female) EUDAMEDGas Sampling Line-2.0M (Female/Female) GUDID
- Generic Name
- Oxygen administration tubing
- Device Name
- Gas Sampling line, (Female/ Female), 7ft
- Model / Reference
- OT-83320
- Primary DI / UDI-DI
- D-OT-833208R EUDAMED04716770833200 GUDID
- Basic UDI-DI
- B-OT-833208R
- 510(k) Number
- FDA Product Code
- CCK
- EMDN Code
- R03010207 Oxygen therapy kits
- GMDN Term
- Oxygen administration tubing
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 868.1400
- Market of Registration
- Germany
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Primary DI / UDI-DI | D-OT-833208R | 04716770833200 |
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- TW-MF-000007246
- Authorised representative
- mdi Europa GmbH DE-AR-000006218
Other devices from Besmed Health Business Corp.
Properties & raw data
Show properties, registry sources and raw records
Other properties (16)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
Sources (2)
- EUDAMED f585b2f9-f155-4bdb-b608-767afefb874f
- FDA UDI 8fc9a424-8592-4fe0-814b-d7f0c4c53829