FDA UDI
In Commercial Distribution
🇺🇸 United States
McKesson
DI: 20612479247684
·
Model: 191-MIS-1130
·
MCKESSON MEDICAL-SURGICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
60
Basic Information
- Brand Name
- McKesson
- Primary DI
- 20612479247684
- Version / Model
- 191-MIS-1130
- Company Name
- MCKESSON MEDICAL-SURGICAL INC.
- Labeler DUNS
- 023904428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 60
- Record Status
- Published
- Publish Date
- 2019-10-04
- Public Version
- 1
- Public Version Date
- 2019-10-14
- Public Version Status
- New
- Public Device Record Key
- 0acb741d-65b8-45ba-ae78-140dd2098a3b
Device Description
Normal Saline IV Flush Syringe; 10 ml fill in 12ml Syringe
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
- Yes
- 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 |
|---|---|---|---|---|
| 46309 | Vascular catheter flush syringe | A sterile device consisting of a barrel (cylinder) with plunger intended to be used to wash the lumen of a vascular access catheter in situ with a rush of solution to maintain patency. It is prefilled with a saline or low-dose heparin solution, and is typically used when a patient has an intravenous (IV) access device in place. It is not intended for dry product reconstitution, for medication dilution, or where IV therapy with sodium chloride (NaCl) or heparin is indicated. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40612479247695 | GS1 | Case | 16 | In Commercial Distribution | |
| Primary | 20612479247684 | GS1 | ||||
| Unit of Use | 10612479247670 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K091583 | 000 |