Identity
- Trade Name
- K-Shield Advantage Blood Drawing Kit FDA UDI
- Generic Name
- Phlebotomy kit FDA UDI
- Device Name
- The Blood Drawing Kit with Antineedle Stick Protector is a single use, sterile transfer set designed for vascular access for blood withdrawal. Use of the Needleless Access Connector allows the clinician needle-free blood withdrawal when blood sampling is required. The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles. This device is not intended for blood transfusion. FDA UDI
- Model / Reference
- BK-64A FDA UDI
- Description
- The Blood Drawing Kit with Antineedle Stick Protector is a single use, sterile transfer set designed for vascular access for blood withdrawal. Use of the Needleless Access Connector allows the clinician needle-free blood withdrawal when blood sampling is required. The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles. This device is not intended for blood transfusion. FDA UDI
Identifiers
- Catalog Number
- BK-64A FDA UDI
- Primary DI / UDI-DI
- 04987488104139 FDA UDI
- FDA Product Code
- KSB FDA UDI
- GMDN Term
- Phlebotomy kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9875 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
Yes
FDA UDI
Category: Phlebotomy kit
K-Shield Advantage Blood Drawing Kit by Sb-Kawasumi Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Sb-Kawasumi Laboratories, Inc.
Sources (1)
- FDA UDI 997e02ad-aa47-4e84-8a81-a4f145dcd349 35 fields · synced May 30, 2026