FDA UDI
In Commercial Distribution
🇺🇸 United States
ST AIA-PACK BNP
DI: 14560189212876
·
Model: N/A
·
TOSOH CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
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Basic Information
- Brand Name
- ST AIA-PACK BNP
- Primary DI
- 14560189212876
- Version / Model
- N/A
- Catalog Number
- 0025228
- Company Name
- TOSOH CORPORATION
- Labeler DUNS
- 690571724
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2021-01-01
- Public Version
- 3
- Public Version Date
- 2024-04-01
- Public Version Status
- Update
- Public Device Record Key
- aa8f678b-2844-4646-bc92-dc4c7708ce72
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
- 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 |
|---|---|---|---|---|
| NBC | Test, Natriuretic Peptide | Clinical Chemistry | 862.1117 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47350 | B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of B-type natriuretic protein (BNP) and/or N-terminal pro b-type natriuretic peptide (NT-proBNP) in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 04560189212879 | GS1 | ||||
| Primary | 14560189212876 | GS1 |
Customer Contacts
- Phone
- 650-615-8134
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius