FDA UDI
In Commercial Distribution
🇺🇸 United States
PIVO 22G
DI: 00850984007034
·
Model: 202-0006
·
VELANO VASCULAR, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PIVO 22G
- Primary DI
- 00850984007034
- Version / Model
- 202-0006
- Company Name
- VELANO VASCULAR, INC.
- Labeler DUNS
- 079714011
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-11
- Public Version
- 5
- Public Version Date
- 2019-04-23
- Public Version Status
- Update
- Public Device Record Key
- 10e3e75d-21db-4334-8fac-0a0b4958548a
Device Description
PIVO (2.0) 22G Compatible device
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
- No
- 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 |
|---|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | 862.1675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37566 | Blood collection tube holder, single-use | A hand-held cylindrical device 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 into which the blood collection tube is inserted and to which the user attaches a hypodermic blood collection needle (not included); it may include an integrated blood collection tube spike. This device 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 |
|---|---|---|---|---|---|---|
| Primary | 00850984007034 | GS1 | ||||
| Package | 10850984007031 | GS1 | Sales Carton | 50 | In Commercial Distribution |
Customer Contacts
- Phone
- 844 835 2668
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K163508 | 000 |