FDA UDI
In Commercial Distribution
🇺🇸 United States
FAMILY WELLNESS
DI: 00032251689659
·
Model: SKU903756
·
Family Dollar Stores
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
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Basic Information
- Brand Name
- FAMILY WELLNESS
- Primary DI
- 00032251689659
- Version / Model
- SKU903756
- Company Name
- Family Dollar Stores
- Labeler DUNS
- 117310689
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2025-08-01
- Public Version
- 2
- Public Version Date
- 2025-12-16
- Public Version Status
- Update
- Public Device Record Key
- d0d74350-6f1e-4533-a066-961e78479bff
Device Description
FW FIRST SIGNAL PREG TEST 2CT
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | Clinical Chemistry | 862.1155 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43774 | Human chorionic gonadotropin alpha-subunit IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of alpha-subunit human chorionic gonadotropin (alpha-HCG) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20032251689653 | GS1 | Case | 24 | In Commercial Distribution | |
| Primary | 00032251689659 | GS1 | ||||
| Unit of Use | 10032251689656 | GS1 |