FDA UDI
In Commercial Distribution
🇺🇸 United States
OneTouch Ultra
DI: 00353885006231
·
Model: 021-416
·
LifeScan Europe GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- OneTouch Ultra
- Primary DI
- 00353885006231
- Version / Model
- 021-416
- Catalog Number
- 021-416
- Company Name
- LifeScan Europe GmbH
- Labeler DUNS
- 480240820
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-25
- Public Version
- 1
- Public Version Date
- 2019-12-03
- Public Version Status
- New
- Public Device Record Key
- 1bd4c6a5-b0d8-4939-b9b1-a68945194379
Device Description
One Touch Ultra Control Solution
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62538 | Glucose monitoring system IVD, point-of-care | A collection of devices including a portable, electrically-powered instrument (meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glucose singularly in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20353885006235 | GS1 | Shipper case | 48 | In Commercial Distribution | |
| Primary | 00353885006231 | GS1 | ||||
| Secondary | 53885-937-01 | NDC/NHRIC |
Customer Contacts
- Phone
- +1 8002278862
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K103553 | 000 |