FDA UDI
In Commercial Distribution
🇺🇸 United States
OneTouch Ping
DI: 00353885011679
·
Model: 023-049
·
LifeScan Europe GmbH
Product Codes
2
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- OneTouch Ping
- Primary DI
- 00353885011679
- Version / Model
- 023-049
- Catalog Number
- 023-049
- Company Name
- LifeScan Europe GmbH
- Labeler DUNS
- 480240820
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-12-14
- Public Version
- 4
- Public Version Date
- 2019-07-26
- Public Version Status
- Update
- Public Device Record Key
- 0e4551fa-cfcf-4733-8226-b103c06eba4a
Device Description
OneTouch Ping Blood Glucose Management System. Meter Remote
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| LZG | PUMP, INFUSION, INSULIN | General Hospital | 880.5725 | 2 |
| CGA | GLUCOSE OXIDASE, GLUCOSE | Clinical Chemistry | 862.1345 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62645 | Glucose analyser IVD, home-use | An electrically-powered instrument intended to be used for the quantitative in vitro measurement of glucose levels in whole blood; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. This analyser is typically included in a blood glucose monitoring system. | No | Active |
| 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 | 20353885011673 | GS1 | Shipper case | 15 | In Commercial Distribution | |
| Primary | 00353885011679 | GS1 |
Customer Contacts
- Phone
- +1(877)937-7867
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K082590 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Hematocrit 30 - 55% | ||
| Device Size Text, specify | Blood Glucose measurement Level mg/dL | ||
| Needle Gauge | 28 | Gauge |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not refrigerate
- Type
- Storage Environment Temperature
- Temperature Range
- High: 86 Degrees Fahrenheit