Identity
- Trade Name
- BD SurePrep™ Capillary Tubes- PLAIN FDA UDI
- Generic Name
- Capillary blood collection tube IVD, no additive FDA UDI
- Device Name
- BD SurePrep™ Capillary Tubes- PLAIN FDA UDI
- Model / Reference
- 420314 FDA UDI
- Description
- BD SurePrep™ Capillary Tubes- PLAIN FDA UDI
Identifiers
- Catalog Number
- 420314 FDA UDI
- Primary DI / UDI-DI
- 30382904203147 FDA UDI
- 510(k) Number
- K884623 FDA UDI
- FDA Product Code
- GIO FDA UDI
- GMDN Term
- Capillary blood collection tube IVD, no additive 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, no additive
BD SurePrep™ Capillary Tubes- PLAIN by Becton Dickinson And Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Capillary blood collection tube IVD, no additive.
- Marketlab Inc — MARKETLAB INC. · Class II
- Minivette® POCT 100µl — Sarstedt Aktiengesellschaft & Co.KG · Class I
- E-Z Safe Tubes — Airscan, Inc. · Class I
- Marketlab Inc — MARKETLAB INC. · Class II
- Marketlab Inc — MARKETLAB INC. · Class I
- Globe Scientific — GLOBE SCIENTIFIC, LLC · Class I
- DCA® Systems Microalbumin/Creatinine Capillary holders and plungers — Siemens Healthcare Diagnostics · Class I
- 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- HEPARINIZED — 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 65d98f68-e331-4751-abbc-e64245b1c952 37 fields · synced May 30, 2026