FDA UDI In Commercial Distribution 🇺🇸 United States

AMSure® Enteral Feeding Irrigation Tray

DI: 10704411008538 · Model: 1 · AMSINO INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
AMSure® Enteral Feeding Irrigation Tray
Primary DI
10704411008538
Version / Model
1
Catalog Number
ENK136
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
96bf51f6-eaca-4259-bb56-4bf58b59f6eb

Device Description

AMSure® Enteral Feeding Irrigation Tray CONTENTS: · 1000cc Outer Tray · 500cc Graduated Container · 60cc Thumb Control Ring Piston Syringe with ENFit Tip · Tip Protector · Alcohol Prep Pad · Large Moisture-Proof Underpad

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
Yes
Sterilization Prior Use
No

Product Codes

Code Name
KNT Tubes, Gastrointestinal (And Accessories)

GMDN Terms

Code Name
11677 Enteral feeding kit, adult/paediatric, sterile

Identifiers

Type ID
Package 40704411008539
Primary 10704411008538