Cardinal Health
by Jiangsu Caina Medical Co., Ltd. China EUDAMEDGUDID
Ref 8881511336Model 0.5mL 30Gx5/16"(0.3x8mm) Product code FMFEMDN A0201060301
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-06971564467537 | Date19 Dec 2023 | StatusActive |
| United States | GUDID listing GUDID | Number06971564467537 | Date8 Jul 2023 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Generic Name
- Insulin syringe/needle, safety
- Device Name
- Disposable Safelock Blood Collection Sets
- Model / Ref / Catalog
- 0.5mL 30Gx5/16"(0.3x8mm), 8881511336, 0.5ml 30Gx5/16"
- Primary DI / UDI-DI
- 06971564467537
- Basic UDI-DI
- B-06971564467537
- 510(k) Number
- FDA Product Code
- FMF
- EMDN Code
- A0201060301 Insulin syringes with safety systems and fixed needles, single-use
- GMDN Term
- Insulin syringe/needle, safety
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 880.5860
- Market of Registration
- Germany
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | 0.5mL 30Gx5/16"(0.3x8mm) 8881511336 | 0.5ml 30Gx5/16" |
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- CN-MF-000011217
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Jiangsu Caina Medical Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (16)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
Sources (2)
- EUDAMED 756e9b5a-f575-473b-b925-feb70e6688e2
- FDA UDI ca319c95-317a-4990-b59f-cdb380c0b609