FDA UDI In Commercial Distribution 🇺🇸 United States

AMSure® Piston Enteral Irrigation Syringe

DI: 10704411008477 · Model: 1 · AMSINO INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
AMSure® Piston Enteral Irrigation Syringe
Primary DI
10704411008477
Version / Model
1
Catalog Number
AS015
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
5
Public Version Date
2021-10-29
Public Version Status
Update
Public Device Record Key
5176f4ac-d687-48db-b2a9-05cfd3327891

Device Description

AMSure® Piston Enteral Irrigation Syringe Contents: • 1 Thumb Control Ring • 60ml/2oz • 1 Tip Protector • 1 Small Tube 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
Yes
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
KYZ Syringe, Irrigating (Non Dental)

GMDN Terms

Code Name
59040 ENFit oral/enteral syringe, single-use

Identifiers

Type ID
Package 40704411008478
Primary 10704411008477