FDA UDI
In Commercial Distribution
🇺🇸 United States
Nipro SafeTouch IV Catheter
DI: 00383790011136
·
Model: NI-CSF2225PET
·
NIPRO MEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Nipro SafeTouch IV Catheter
- Primary DI
- 00383790011136
- Version / Model
- NI-CSF2225PET
- Company Name
- NIPRO MEDICAL CORPORATION
- Labeler DUNS
- 797372554
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-15
- Public Version
- 1
- Public Version Date
- 2022-10-24
- Public Version Status
- New
- Public Device Record Key
- 5ff1ac48-54de-4c51-b76a-0b2a22450525
Device Description
Safety IV Catheter, Straight type (22Gx1")
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 |
|---|---|---|---|---|
| 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 | 10383790011133 | GS1 | Box | 50 | In Commercial Distribution | |
| Primary | 00383790011136 | GS1 | ||||
| Package | 40383790011134 | GS1 | Case | 40 | In Commercial Distribution |
Customer Contacts
- Phone
- +1 908-393-7030
- [email protected]