FDA UDI
In Commercial Distribution
🇺🇸 United States
GoodSense
DI: 30370030128397
·
Model: 8000-10284
·
L PERRIGO COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
25
Basic Information
- Brand Name
- GoodSense
- Primary DI
- 30370030128397
- Version / Model
- 8000-10284
- Company Name
- L PERRIGO COMPANY
- Labeler DUNS
- 006013346
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2018-12-03
- Public Version Status
- Update
- Public Device Record Key
- 2303f69e-93b2-4dfb-9644-a61398be0b74
Device Description
Test Strips, GoodSense, Premium, 25CT
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
- No
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62537 | Glucose monitoring system IVD, home-use | A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 30370030128397 | GS1 | ||||
| Unit of Use | 40370030128394 | GS1 | ||||
| Package | 00370030128396 | GS1 | Carton | 1 | In Commercial Distribution | |
| Package | 10370030128393 | GS1 | shipper | 24 | In Commercial Distribution |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 8 – 30 Degrees Celsius