FDA UDI
In Commercial Distribution
🇺🇸 United States
CVS Health At Home
DI: 00860008357816
·
Model: Vitamin D collection kit
·
Blackfly Investments, LLC
Product Codes
0
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CVS Health At Home
- Primary DI
- 00860008357816
- Version / Model
- Vitamin D collection kit
- Catalog Number
- 50428656679
- Company Name
- Blackfly Investments, LLC
- Labeler DUNS
- 069497839
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-20
- Public Version
- 2
- Public Version Date
- 2022-11-23
- Public Version Status
- Update
- Public Device Record Key
- 7a13d597-7188-4713-b308-19dd2e4e0ebe
Device Description
Dry blood spot collection kit using 903 Five Spot Blood card
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63134 | Dried blood spot collection kit IVD | A collection of devices and materials intended to be used by a healthcare professional at the point-of-care to collect a dried blood spot (DBS) specimen from capillary or venous blood, for subsequent diagnostic testing or screening. The kit typically includes a lancet and/or hypodermic needle with a syringe, capillary tube(s), a blood collection strip, dry blood collection card/filter paper card, and other items (e.g., alcohol prep pad, disposable lancet, gauze pad, bandage strip, and a container with a requisition form, for mailing to the laboratory). This is a single-use device. | No | Active |
| 45522 | Blood collection paper | A non-sterile filter-paper card intended to be used as a medium for the collection and transport of blood specimen spots to a laboratory for testing. It provides a uniform surface for the collection of blood spot specimens taken from the patient. Also known as an Ahlstrom 226 specimen collection paper or a Whatman body fluid collection paper, it may incorporate a tear-apart form for demographic information. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860008357816 | GS1 |