Identity
- Trade Name
- Double Dove FDA UDI
- Generic Name
- General-purpose syringe/needle FDA UDI
- Device Name
- Sterile hypodermic syringe for single use, with needle, is intended to be used for medical purposes to inject fluid into or withdraw fluid from the body. Volume: 1mL; Needle size: 0.50*38mm RWLB; Nozzle type: Luer Lock. FDA UDI
- Model / Reference
- 0204 FDA UDI
- Description
- Sterile hypodermic syringe for single use, with needle, is intended to be used for medical purposes to inject fluid into or withdraw fluid from the body. Volume: 1mL; Needle size: 0.50*38mm RWLB; Nozzle type: Luer Lock. FDA UDI
Identifiers
- Catalog Number
- 0204 FDA UDI
- Primary DI / UDI-DI
- 06934755702046 FDA UDI
- 510(k) Number
- K090929 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- General-purpose syringe/needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General-purpose syringe/needle
Double Dove by Jumin Bio-Technologies, Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K090929 also covers:
- Double Dove — Jumin Bio-Technologies, Co., Ltd.
- Double Dove — Jumin Bio-Technologies, Co., Ltd.
- Double Dove — Jumin Bio-Technologies, Co., Ltd.
- Double Dove — Jumin Bio-Technologies, Co., Ltd.
- Double Dove — Jumin Bio-Technologies, Co., Ltd.
- Double Dove — Jumin Bio-Technologies, Co., Ltd.
- Double Dove — Jumin Bio-Technologies, Co., Ltd.
- Double Dove — Jumin Bio-Technologies, Co., Ltd.
- Double Dove — Jumin Bio-Technologies, Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Jumin Bio-Technologies, Co., Ltd.
Sources (1)
- FDA UDI 60063586-0025-4bb1-8093-ed09e7ab4114 35 fields · synced May 30, 2026