FDA UDI
In Commercial Distribution
🇺🇸 United States
WOLF-PAK Self Safe IV Catheter
DI: 08032248373877
·
Model: 3738760
·
DELTA MED SPA
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- WOLF-PAK Self Safe IV Catheter
- Primary DI
- 08032248373877
- Version / Model
- 3738760
- Company Name
- DELTA MED SPA
- Labeler DUNS
- 444776777
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-30
- Public Version
- 1
- Public Version Date
- 2020-05-08
- Public Version Status
- New
- Public Device Record Key
- 5e121a2f-6968-462e-958c-74196de45a44
Device Description
IV safety catheter
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 |
|---|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | 880.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64574 | Peripheral intravenous cannula | A short, thin tube intended to be inserted into a peripheral vein (typically on the hand/arm) to enable short-term (< 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. Also referred to as a peripheral IV catheter, it is typically assembled with a dedicated introduction needle, and usually includes connectors, injection ports, and wings for fixation. It is not intended to be advanced to the central vasculature. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 38032248373878 | GS1 | case | 50 | In Commercial Distribution | |
| Primary | 08032248373877 | GS1 | ||||
| Package | 58032248373872 | GS1 | box | 4 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 25 | Millimeter | |
| Device Size Text, specify | Gauge 20 | ||
| Outer Diameter | 1.00 | Millimeter |