60-60-209
Part of a family of 30 devices: see the family page
Ref 60-60-209
Active
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Overview
This tube inhaler from VBM Medizintechnik GmbH is designed for the creation of a direct connection between breathing circuits, anesthesia face masks, or other non-sampling breathing circuit components. It's typically made of plastic materials and has a straight or elbow-shaped design, allowing for partial rotation at the point of connection. This reusable device is ideal for pediatric to adult sizes and can be used with standard MDI canisters and suction ports.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number42501056-2.4.0-r-NT 04250105600902 | Date23 Feb 2026 | StatusActive |
| United States | GUDID listing GUDID | Number04250105600902 | Date31 Aug 2020 | StatusListed |
Official records
- EUDAMED public site 42501056-2.4.0-r-NT
- AccessGUDID record 04250105600902
Across registries
- EUDAMED Basic UDI-DI 42501056-2.4.0-r-NT registered 23 Feb 2026 Active
- FDA GUDID UDI-DI 04250105600902 listed 31 Aug 2020 Listed
Timeline
- Listed FDA GUDID 04250105600902
- Registered EUDAMED 42501056-2.4.0-r-NT
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Tube Inhaler; 15 mm I.D. / 22 mm O.D. ; 15 mm O.D. for standard MDI canisters, suction port max. 16 Fr
- Generic name
- Straight/elbow breathing circuit connector, reusable
- Device name
- Connectors - Connector Reusable
- Model / reference
- 60-60-209
- Primary DI / UDI-DI
- 04250105600902
- Basic UDI-DI
- 42501056-2.4.0-r-NT
- FDA product code
- BZA
- EMDN code
- R020302 Respiratory circuits adapters and connectors
- GMDN term
- Straight/elbow breathing circuit connector, reusable
- Device class
- Class IIa EUDAMEDClass I GUDID
- Regulation number
- 868.5810
- EU registration type
- Standard device
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class IIa | Class I |
| Sterilise before use | Yes | No |
Registry differences
EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:
- Sterilise before use UDI-DI 04250105600902: EUDAMED states Yes, FDA GUDID states No.
Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.
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