FDA UDI
In Commercial Distribution
🇺🇸 United States
Henry Schein
DI: 00304040103975
·
Model: 5701322
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Henry Schein
- Primary DI
- 00304040103975
- Version / Model
- 5701322
- Catalog Number
- 5701322
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-11
- Public Version
- 1
- Public Version Date
- 2019-02-11
- Public Version Status
- New
- Public Device Record Key
- 9f1884b8-9674-4188-b6ab-c21a0415c086
Device Description
OneStepTM + Pro Hb Optical System Check
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| GKR | SYSTEM, HEMOGLOBIN, AUTOMATED | Hematology | 864.5620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55874 | Total haemoglobin (totHb) IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of total haemoglobin (totHb) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00304040103975 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 35 Degrees Celsius