FDA UDI
In Commercial Distribution
🇺🇸 United States
JJ CARE
DI: 15060988910038
·
Model: HH-X-T
·
Jack Jack LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
4951
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- JJ CARE
- Primary DI
- 15060988910038
- Version / Model
- HH-X-T
- Company Name
- Jack Jack LLC
- Labeler DUNS
- 052514128
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4951
- Record Status
- Published
- Publish Date
- 2023-03-15
- Public Version
- 1
- Public Version Date
- 2023-03-23
- Public Version Status
- New
- Public Device Record Key
- 8350272f-ded1-439b-a7c3-49c3f1369070
Device Description
Lancing Device- People with diabetes may use a lancet to test and monitor their blood glucose levels. Regular testing can help people manage their diabetes symptoms.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- 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 |
|---|---|---|---|---|
| QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | General, Plastic Surgery | 878.4850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37243 | Manual blood lancing device, reusable | A hand-held manual instrument intended to be used for controlled skin puncture to obtain a capillary blood specimen (e.g., performed by a diabetic patient) typically at the fingertip or ear lobe. It is used with a sterile, disposable lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15060988910038 | GS1 | ||||
| Package | 25060988910035 | GS1 | Case | 150 | In Commercial Distribution | |
| Unit of Use | 05060988910031 | GS1 |
Customer Contacts
- Phone
- 18334201183
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | No Device Sizes |