FDA UDI
In Commercial Distribution
🇺🇸 United States
NURSE ASSIST
DI: 00850421008921
·
Model: 1210-SF
·
NURSE ASSIST, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- NURSE ASSIST
- Primary DI
- 00850421008921
- Version / Model
- 1210-SF
- Company Name
- NURSE ASSIST, INC.
- Labeler DUNS
- 869434464
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-10
- Public Version
- 1
- Public Version Date
- 2024-07-18
- Public Version Status
- New
- Public Device Record Key
- fa4b6324-fe39-4243-9475-7220a5db2438
Device Description
0.9% Sodium Chloride IV Flush Syringe for Sterile Delivery, 10mL Fill, 1210-SF, Syringe/Pouch
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| NGT | Saline, Vascular Access Flush | General Hospital | 880.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64786 | Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial | A solution (e.g., saline, sterile water) intended to flush the lumen of an in situ intravenous access device (IVAD), typically a peripheral intravenous cannula or central venous catheter, to maintain patency; it does not include an anticoagulant or antimicrobial agent. Also known as lock solution, the device is available in a small container (e.g., bottle) or prefilled syringe. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850421008928 | GS1 | Inner Pack | 30 | In Commercial Distribution | |
| Primary | 00850421008921 | GS1 | ||||
| Package | 20850421008925 | GS1 | Outer Case | 8 | In Commercial Distribution |