FDA UDI In Commercial Distribution 🇺🇸 United States

AMSafe ® Pre-Filled Normal Saline Flush Syringe

DI: 30704411015141 · Model: 1 · AMSINO INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
AMSafe ® Pre-Filled Normal Saline Flush Syringe
Primary DI
30704411015141
Version / Model
1
Catalog Number
IVF1010TM
Company Name
AMSINO INTERNATIONAL, INC.
Labeler DUNS
825673239
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-11-09
Public Version
2
Public Version Date
2022-11-28
Public Version Status
Update
Public Device Record Key
c5dd7e6e-db01-4696-9a43-e8d54123aa86

Device Description

AMSafe ® Pre-Filled Normal Saline Flush Syringe , 10 mL 0.9% Sodium Chloride Injection, USP

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
NGT Saline, Vascular Access Flush

GMDN Terms

Code Name
64871 Non-antimicrobial wound irrigation solution, saline

Identifiers

Type ID
Primary 30704411015141
Package 40704411015148