Identity
- Trade Name
- CAINA FDA UDI
- Generic Name
- Blood collection set, invasive FDA UDI
- Device Name
- The Safelock disposable blood collection sets are intended to be used with vacuum blood collection tube for venipuncture to collect blood specimens from patients, and the safety sheath is designed to prevent accidental needlesticks. FDA UDI
- Model / Reference
- 25G*3/4"*12" FDA UDI
- Description
- The Safelock disposable blood collection sets are intended to be used with vacuum blood collection tube for venipuncture to collect blood specimens from patients, and the safety sheath is designed to prevent accidental needlesticks. FDA UDI
Identifiers
- Catalog Number
- SBCN25G7512C FDA UDI
- Primary DI / UDI-DI
- 06971564465939 FDA UDI
- 510(k) Number
- K151991 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Blood collection set, invasive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 25 Gauge FDA UDILength — 0.75 Inch FDA UDILength — 12 Inch FDA UDI
Category: Blood collection set, invasive
Caina by Jiangsu Caina Medical Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K151991 also covers:
- 8943 SecureSafe Safety Blood Collection Set w/ Tube Holder, 21G, 3/4" Needle, 4/ — Dynarex Corp.
- 8944 SecureSafe Safety Blood Collection Set w/ Tube Holder, 23G, 3/4" Needle, 4/ — Dynarex Corp.
- 8945 SecureSafe Safety Blood Collection Set w/ Tube Holder, 25G, 3/4" Needle, 4/ — Dynarex Corp.
- Blood Collection Set — Dynarex Corp.
- Blood Collection Set — Dynarex Corp.
- Blood Collection Set — Dynarex Corp.
- CAINA — Jiangsu Caina Medical Co., Ltd
- CAINA — Jiangsu Caina Medical Co., Ltd
- CAINA — Jiangsu Caina Medical Co., Ltd
- SafeTPoint — Jiangsu Caina Medical Co., Ltd
- SafeTPoint — Jiangsu Caina Medical Co., Ltd
- SafeTPoint — Jiangsu Caina Medical 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
- Jiangsu Caina Medical Co., Ltd
Sources (1)
- FDA UDI aa33b249-4113-4e0c-a70c-c733b39b2c4c 36 fields · synced May 30, 2026