FDA UDI
In Commercial Distribution
🇺🇸 United States
HEPRO.US Lancets MM1000 470 Boxes
DI: 00854427007162
·
Model: CT - Lancets 470 boxes
·
HEPRO.US INC.
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
450
Basic Information
- Brand Name
- HEPRO.US Lancets MM1000 470 Boxes
- Primary DI
- 00854427007162
- Version / Model
- CT - Lancets 470 boxes
- Company Name
- HEPRO.US INC.
- Labeler DUNS
- 080061451
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 450
- Record Status
- Published
- Publish Date
- 2017-06-21
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- cf60c625-122e-4ebc-a066-baa1080c3a0c
Device Description
HEPRO.US Lancets MM1000 1 Case of 450 Boxes
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMK | Lancet, Blood | General, Plastic Surgery | 878.4850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61579 | Blood lancet, single-use | A sterile, hand-held, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare provider to manually puncture the skin of a patient to obtain a small blood specimen or drain a cyst or boil. This is a single-use device. | No | Active |
| 61578 | Manual blood lancing device, single-use | A sterile, hand-held manual instrument intended to be used for controlled skin puncture/cut to obtain a capillary blood specimen, performed by a healthcare provider (e.g., on a neonate) or a patient (e.g., a diabetic), typically at the fingertip or ear lobe. It includes a preloaded 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 single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00854427007162 | GS1 | ||||
| Unit of Use | 85442700716202 | GS1 |