Identity
- Trade Name
- BD SurePrep™ Capillary Tubes- HEPARINIZED FDA UDI
- Generic Name
- Capillary blood collection tube IVD, ammonium heparin FDA UDI
- Device Name
- BD SurePrep™ Capillary Tubes- HEPARINIZED FDA UDI
- Model / Reference
- 420317 FDA UDI
- Description
- BD SurePrep™ Capillary Tubes- HEPARINIZED FDA UDI
Identifiers
- Catalog Number
- 420317 FDA UDI
- Primary DI / UDI-DI
- 30382904203178 FDA UDI
- 510(k) Number
- K884623 FDA UDI
- FDA Product Code
- GIO FDA UDI
- GMDN Term
- Capillary blood collection tube IVD, ammonium heparin FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.6150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Category: Capillary blood collection tube IVD, ammonium heparin
BD SurePrep™ Capillary Tubes- HEPARINIZED by Becton Dickinson And Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Capillary blood collection tube IVD, ammonium heparin.
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- SAFE-T-FILL® — Ram Scientific · Class II
- Globe Scientific — GLOBE SCIENTIFIC, LLC · Class I
Cleared under the same submission
K884623 also covers:
- E-Z Safe Tubes — Airscan, Inc.
- BD SurePrep™ Capillary Tubes- HEPARINIZED — BECTON DICKINSON AND COMPANY
- BD SurePrep™ Capillary Tubes- PLAIN — BECTON DICKINSON AND COMPANY
- BD SurePrep™ Capillary Tubes- PLAIN — BECTON DICKINSON AND COMPANY
- BD SurePrep™ Capillary Tubes- PRECALIBRATED — BECTON DICKINSON AND COMPANY
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (1)
- FDA UDI 8114bbf6-2acd-4035-8817-8b45bf92ca48 37 fields · synced Jun 8, 2026