FDA UDI
In Commercial Distribution
🇺🇸 United States
PremierPro Lancet
DI: 00811220030360
·
Model: 7552
·
SVS LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PremierPro Lancet
- Primary DI
- 00811220030360
- Version / Model
- 7552
- Catalog Number
- 7552
- Company Name
- SVS LLC
- Labeler DUNS
- 831375089
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-03
- Public Version
- 3
- Public Version Date
- 2022-11-21
- Public Version Status
- Update
- Public Device Record Key
- 4665e27a-5009-48b3-b11f-3dd49a28c93d
Device Description
Lancet, Pressure, BLUE Instructions for use 1. Twist off the protective cap and pull it straight out. 2. Press the safety lancet body firmly against the puncture site to activate the device. 3. Gently apply intermittent pressure near the puncture site to obtain the required blood volume. Warnings 1. Do not use if protective cap has been previously removed from lancet. 2. Clean the injection site prior to use following established procedure. 3. Discard used lancet into a sharps container in accordance with facility guidelines, national and state regulations.
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| 45142 | Blood lancing device tip | A sterile, sharp, needle-like device intended to be loaded into a blood lancing device to function as the invasive portion of the assembly during skin puncture for capillary blood sampling, typically performed at a fingertip or ear lobe (e.g., by diabetic patients). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10811220030367 | GS1 | case | 100 | In Commercial Distribution | |
| Primary | 00811220030360 | GS1 |
Customer Contacts
- Phone
- 1-855-531-7699
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 25G x 1.8mm, Blue, 100/bx |