FDA UDI
In Commercial Distribution
🇺🇸 United States
OneTouch Ultra Blue
DI: 00353885004183
·
Model: 020-963
·
LifeScan Europe GmbH
Product Codes
2
GMDN Terms
1
Identifiers
5
Pkg Device Count
50
Basic Information
- Brand Name
- OneTouch Ultra Blue
- Primary DI
- 00353885004183
- Version / Model
- 020-963
- Catalog Number
- 020-963
- Company Name
- LifeScan Europe GmbH
- Labeler DUNS
- 480240820
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2017-09-13
- Public Version
- 4
- Public Version Date
- 2019-07-26
- Public Version Status
- Update
- Public Device Record Key
- eb86d4c4-9a92-4aa1-8054-64d3ab25d8a7
Device Description
OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2, OneTouch UltraMini, OneTouch Ultra, OneTouch UltraSmart, OneTouch Ping and OneTouch UltraLink Meters
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | Clinical Chemistry | 862.1345 | 2 |
| CGA | GLUCOSE OXIDASE, GLUCOSE | Clinical Chemistry | 862.1345 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53303 | Glucose IVD, kit, electrometry | A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20353885004187 | GS1 | Shipper case | 128 | In Commercial Distribution | |
| Primary | 00353885004183 | GS1 | ||||
| Unit of Use | 80353885004189 | GS1 | ||||
| Package | 30353885004184 | GS1 | Shipper case | 240 | In Commercial Distribution | |
| Secondary | 53885-963-50 | NDC/NHRIC |
Customer Contacts
- Phone
- +1(800)227-8862
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store your test strips in their original vial only.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do Not Refrigerate
- Type
- Special Storage Condition, Specify
- Special Conditions
- Use within 6 months of opening test strip vial.
- Type
- Storage Environment Temperature
- Temperature Range
- High: 86 Degrees Fahrenheit