FDA UDI
In Commercial Distribution
🇺🇸 United States
i-STAT
DI: 10054749001009
·
Model: 05p58-25
·
ABBOTT POINT OF CARE INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- i-STAT
- Primary DI
- 10054749001009
- Version / Model
- 05p58-25
- Catalog Number
- 05p58-25
- Company Name
- ABBOTT POINT OF CARE INC.
- Labeler DUNS
- 079226216
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-09
- Public Version
- 4
- Public Version Date
- 2023-09-11
- Public Version Status
- Update
- Public Device Record Key
- 55322f58-51af-4fcf-997f-63ce51f9338d
Device Description
CARTRIDGE, Total B-hCG
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DHA | System, Test, Human Chorionic Gonadotropin | Clinical Chemistry | 862.1155 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54212 | Total human chorionic gonadotropin IVD, reagent | A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of total human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10054749001009 | GS1 | ||||
| Package | 00054749001002 | GS1 | Case | 25 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)366-8020
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K133002 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius