FDA UDI
Not in Commercial Distribution
🇺🇸 United States
GL GoodLife Glucose Control Solutions
DI: 00389154000549
·
Model: 3C-01-160032
·
HMD BIOMEDICAL INC.
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- GL GoodLife Glucose Control Solutions
- Primary DI
- 00389154000549
- Version / Model
- 3C-01-160032
- Catalog Number
- 3C-01-160032
- Company Name
- HMD BIOMEDICAL INC.
- Labeler DUNS
- 658644174
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-17
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 24d16c22-4bba-4589-bbac-be7367ecc221
- Distribution End Date
- 2017-03-06
Device Description
GL GoodLife Glucose Control Solution
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
- 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 |
| LFR | Glucose Dehydrogenase, Glucose | Clinical Chemistry | 862.1345 | 2 |
| NBW | System, Test, Blood Glucose, Over The Counter | Clinical Chemistry | 862.1345 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41819 | Glucose IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00389154000549 | GS1 | ||||
| Package | 00389154000563 | GS1 | 792 | Not in Commercial Distribution | 2017-03-06 |
Customer Contacts
- Phone
- 1-855-692-3511
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K113307 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 86 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius