Identity
- Trade Name
- CAINA FDA UDI
- Generic Name
- Blood collection set, invasive FDA UDI
- Device Name
- The Safety 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 aid in the reduction of accidental needlesticks. FDA UDI
- Model / Reference
- 23G*3/4"*12" FDA UDI
- Description
- The Safety 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 aid in the reduction of accidental needlesticks. FDA UDI
Identifiers
- Catalog Number
- BC032375 FDA UDI
- Primary DI / UDI-DI
- 06971564466042 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 — 23 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
Similar devices
Also classified as Blood collection set, invasive.
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
- Custom Healthcare Systems Inc. — Manus Medical, LLC · Class II
- KBMED — KB Medical (group), Inc. · Class II
- MediChoice — OWENS & MINOR DISTRIBUTION, INC. · Class II
- SOL-CARE™ Safety Blood Collection Needle — Sol-Millennium Medical, Inc. · Class II
- SteriPath Gen2, 23G, BD — MAGNOLIA MEDICAL TECHNOLOGIES, INC. · Class II
- RELI® — MYCO MEDICAL SUPPLIES INC. · Class II
- Custom Healthcare Systems Inc. — Manus Medical, LLC
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 8d5c7144-12a2-47cc-b968-d77e6ea96ac8 36 fields · synced Jun 8, 2026