FDA UDI
In Commercial Distribution
🇺🇸 United States
NIPRO SAFETOUCH™ II SAFETY FISTULA NEEDLE
DI: 00383790000000
·
Model: 14GX1
·
NIPRO MEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- NIPRO SAFETOUCH™ II SAFETY FISTULA NEEDLE
- Primary DI
- 00383790000000
- Version / Model
- 14GX1
- Catalog Number
- FS+142530BC
- Company Name
- NIPRO MEDICAL CORPORATION
- Labeler DUNS
- 797372554
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-20
- Public Version
- 3
- Public Version Date
- 2018-12-20
- Public Version Status
- Update
- Public Device Record Key
- 041227fc-9768-4ffe-8962-9cfcfe1b1247
Device Description
14Gx1" Fixed Hub 11" Tubing
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
- No
- 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 |
|---|---|---|---|---|
| 12741 | Haemodialysis needle | A sterile, sharp bevel-edged, hollow tubular metal instrument used to remove and return a patient's blood during a haemodialysis procedure. Commonly known as a dialysis needle. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10383790000007 | GS1 | Carton | 50 | In Commercial Distribution | |
| Primary | 00383790000000 | GS1 | ||||
| Package | 40383790000008 | GS1 | Case | 10 | In Commercial Distribution |