FDA UDI
In Commercial Distribution
🇺🇸 United States
WowGoHealth Blood Glucose Test Strips - GSH-BGM902 - 2*25
DI: 04719878121125
·
Model: GSH-BGM902 - 2*25
·
GOLDEN SMART HOME TECHNOLOGY CORP.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
50
Basic Information
- Brand Name
- WowGoHealth Blood Glucose Test Strips - GSH-BGM902 - 2*25
- Primary DI
- 04719878121125
- Version / Model
- GSH-BGM902 - 2*25
- Company Name
- GOLDEN SMART HOME TECHNOLOGY CORP.
- Labeler DUNS
- 656002163
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2019-07-04
- Public Version
- 1
- Public Version Date
- 2019-07-12
- Public Version Status
- New
- Public Device Record Key
- 560cdc4a-2839-48e3-b312-42526b78f2db
Device Description
The WowGoHealth Blood Glucose Test Strip is for the measurement of glucose in whole blood. It is for In-vitro diagnostic use only. And the WowGoHealth test strips can only be used with WowGoHealth meter that has the same reference number.
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 |
|---|---|---|---|---|
| LFR | Glucose Dehydrogenase, 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 |
|---|---|---|---|---|---|---|
| Primary | 04719878121125 | GS1 | ||||
| Unit of Use | 04719878121101 | GS1 | ||||
| Package | 24719878121129 | GS1 | Mid-box | 10 | In Commercial Distribution | |
| Package | 54719878121120 | GS1 | Carton | 12 | In Commercial Distribution |
Customer Contacts
- Phone
- +88635770693
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141351 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius