FDA UDI Not in Commercial Distribution 🇺🇸 United States

AMSure ® Enteral Feeding Flat Top Piston Syringe with ENFit ™ Tip

DI: 10704411014898 · Model: 1 · AMSINO INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
AMSure ® Enteral Feeding Flat Top Piston Syringe with ENFit ™ Tip
Primary DI
10704411014898
Version / Model
1
Catalog Number
ENS115T
Company Name
AMSINO INTERNATIONAL, INC.
Labeler DUNS
825673239
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-10-04
Public Version
1
Public Version Date
2022-10-12
Public Version Status
New
Public Device Record Key
45a32c94-7ab8-4f0a-a698-31074f3c039b
Distribution End Date
2022-10-04

Device Description

The Enteral Feeding Syringe with ENFit Tip connection is intended to connect to Enteral devices with ENFit connectors. CONTENTS: - 60cc Flat Top Piston Syringe(China) - ENFit transition connector(China) - Tip Protector(China)

Device Characteristics

Single Use
No
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
62001 ENFit oral/enteral syringe, reusable

Identifiers

Type ID
Primary 10704411014898