FDA UDI
In Commercial Distribution
🇺🇸 United States
PremierPro Lancet
DI: 00811220033385
·
Model: 7581
·
SVS LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- PremierPro Lancet
- Primary DI
- 00811220033385
- Version / Model
- 7581
- Catalog Number
- 7581
- Company Name
- SVS LLC
- Labeler DUNS
- 831375089
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-08
- Public Version
- 3
- Public Version Date
- 2022-10-24
- Public Version Status
- Update
- Public Device Record Key
- 15fffe3e-3a2f-466e-94f9-304dc4a1c616
Device Description
Blood Transfer Device, Sterile
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | 880.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58284 | Blood collection tube holder/needle | A sterile, hand-held cylindrical device with a pre-attached needle designed to be used together with an evacuated blood collection tube to draw blood samples from a patient. It is typically a hollow plastic adaptor with a pre-attached blood collection needle at one end and into which the blood collection tube is inserted at the other end; this also facilitates a multiple-tube blood collection via one venipuncture. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00811220033392 | GS1 | inner box | 200 | In Commercial Distribution | |
| Primary | 00811220033385 | GS1 | ||||
| Package | 00811220033422 | GS1 | case | 4 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-855-531-7699
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172763 | 000 |