FDA UDI
In Commercial Distribution
🇺🇸 United States
AboutTime MPD 21Gx 1.8mm Safety Lancet
DI: 00628465014525
·
Model: 1
·
Medical Plastic Devices M.P.D. Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- AboutTime MPD 21Gx 1.8mm Safety Lancet
- Primary DI
- 00628465014525
- Version / Model
- 1
- Catalog Number
- P1452
- Company Name
- Medical Plastic Devices M.P.D. Inc
- Labeler DUNS
- 244897773
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2020-02-25
- Public Version
- 1
- Public Version Date
- 2020-03-04
- Public Version Status
- New
- Public Device Record Key
- 23e5e35e-f58f-4368-8f69-c801a234dfb5
Device Description
21G x 1.8mm MPD Safety Lancet Box of 100 Single use Sterile Safe Needle is fully shielded before and after use Sterilized by gamma irradiation Comfortable High Quality Tri-bevel point with high speed penetration Tri-Bevel tip ensures good blood flow Optimal ergonomic design Convenient Pre-loaded and pressure activated device Less pressure power.
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
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 00628465114522 | GS1 | ||||
| Primary | 00628465014525 | GS1 |