FDA UDI In Commercial Distribution 🇺🇸 United States

AMSure® Enteral Irrigation Kit with Piston Syringe

DI: 10704411008491 · Model: 1 · AMSINO INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
AMSure® Enteral Irrigation Kit with Piston Syringe
Primary DI
10704411008491
Version / Model
1
Catalog Number
AS126
Company Name
AMSINO INTERNATIONAL, INC.
Labeler DUNS
825673239
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-06-05
Public Version
1
Public Version Date
2018-07-06
Public Version Status
New
Public Device Record Key
9dca71f8-57d3-4578-88d3-a336665c75ed

Device Description

AMSure® Enteral Irrigation Kit with Piston Syringe Clean, Ready to Use For Single Patient Use Only CONTENTS: • Graduated Container, 500 ml • 1 Piston Irrigation Syringe, 60 ml • 1 Patient I.D. Label • 1 Luer Tip Adapter

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
No
Sterilization Prior Use
No

Product Codes

Code Name
KNT Tubes, Gastrointestinal (And Accessories)

GMDN Terms

Code Name
60445 Enteral feeding kit, adult/paediatric, non-sterile

Identifiers

Type ID
Package 40704411008492
Primary 10704411008491