FDA UDI
In Commercial Distribution
🇺🇸 United States
ATELLICA HA1C_E HIGH VOLUME LABEL KIT
DI: 00630414304311
·
Model: 11597090
·
Siemens Healthcare Diagnostics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ATELLICA HA1C_E HIGH VOLUME LABEL KIT
- Primary DI
- 00630414304311
- Version / Model
- 11597090
- Catalog Number
- 11597090
- Company Name
- Siemens Healthcare Diagnostics Inc.
- Labeler DUNS
- 064608573
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-19
- Public Version
- 1
- Public Version Date
- 2022-05-27
- Public Version Status
- New
- Public Device Record Key
- 87c2ec7b-f1ca-4ec1-bf1f-6d8200ff9774
Device Description
HA1C_E HIGH VOLUME LABEL KIT ATELLICA CH (50 LABELS)
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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | Clinical Chemistry | 862.2160 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63375 | Printer label IVD | A thin, blank sheet of fibrous material, typically with an adhesive underside, intended to be imprinted with an image/text using a printer, and then applied to an object for identification (e.g., barcode) or information associated with an in vitro diagnostic procedure. It is typically available as a continuous roll with individual labels arranged on a waxy backing sheet for easy peeling. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00630414304311 | GS1 |
Customer Contacts
- Phone
- +1(877)229-3711
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- without restrictions