FDA UDI
In Commercial Distribution
🇺🇸 United States
CL AIA-PACK T3 ADJUSTER SET
DI: 14562185395454
·
Model: N/A
·
TOSOH CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CL AIA-PACK T3 ADJUSTER SET
- Primary DI
- 14562185395454
- Version / Model
- N/A
- Company Name
- TOSOH CORPORATION
- Labeler DUNS
- 690571724
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-01
- Public Version
- 1
- Public Version Date
- 2025-09-09
- Public Version Status
- New
- Public Device Record Key
- 701dc6f0-868f-4ce1-8246-8cf64104d741
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| JIT | Calibrator, Secondary | Clinical Chemistry | 862.1150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58333 | Total triiodothyronine (TT3) IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of total triiodothyronine (TT3) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 24562185395451 | GS1 | 40 | In Commercial Distribution | ||
| Primary | 14562185395454 | GS1 |
Customer Contacts
- Phone
- 615-806-4671
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius