FDA UDI
In Commercial Distribution
🇺🇸 United States
ROLLER 10 PLUS NEEDLE
DI: 08056040144497
·
Model: ROLLER 10 PLUS NEEDLE
·
ALIFAX SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ROLLER 10 PLUS NEEDLE
- Primary DI
- 08056040144497
- Version / Model
- ROLLER 10 PLUS NEEDLE
- Catalog Number
- SI R10-PN
- Company Name
- ALIFAX SRL
- Labeler DUNS
- 435930630
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-06
- Public Version
- 1
- Public Version Date
- 2022-10-14
- Public Version Status
- New
- Public Device Record Key
- bfe6b2cd-69a0-4ac5-b8f5-1a0477c91226
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| GKB | Device, Automated Sedimentation Rate | Hematology | 864.5800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56691 | Erthrocyte sedimentation rate (ESR) analyser IVD | An electrically-powered automated or semi-automated laboratory instrument intended to be used to determine the erythrocyte sedimentation rate (ESR) of red blood cells in an anticoagulated whole blood specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08056040144497 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 65 Degrees Celsius