Identity
- Trade Name
- Blood Specimen Return Bag FDA UDI
- Generic Name
- Dried blood spot collection kit IVD FDA UDI
- Device Name
- Blood specimen Return Bag, Non-sterile FDA UDI
- Model / Reference
- F02 FDA UDI
- Description
- Blood specimen Return Bag, Non-sterile FDA UDI
Identifiers
- Catalog Number
- F02 FDA UDI
- Primary DI / UDI-DI
- 00860013988012 FDA UDI
- FDA Product Code
- NNK FDA UDI
- GMDN Term
- Dried blood spot collection kit IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3250 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
Yes
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
- Width — 5.75 Inch FDA UDI
Category: Dried blood spot collection kit IVD
Blood Specimen Return Bag by Advance Dx, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dried blood spot collection kit IVD.
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 |
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Manufacturer
- Manufacturer
- Advance Dx, Inc.
Sources (1)
- FDA UDI 4593b427-d0cf-4b2f-a4ea-d9561636398a 36 fields · synced May 30, 2026