FDA UDI In Commercial Distribution 🇺🇸 United States

Ameritus Oral Syringe

DI: 10817522013251 · Model: AEG1-KMS-BA · KENTEC MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
50

Basic Information

Brand Name
Ameritus Oral Syringe
Primary DI
10817522013251
Version / Model
AEG1-KMS-BA
Catalog Number
AEG1-KMS-BA
Company Name
KENTEC MEDICAL, INC.
Labeler DUNS
066175613
Distribution Status
In Commercial Distribution
Device Count in Pkg
50
Record Status
Published
Publish Date
2020-06-03
Public Version
2
Public Version Date
2021-10-29
Public Version Status
Update
Public Device Record Key
b86543df-a59e-44d1-9d8d-da4233133fae

Device Description

1ml oral syringe

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
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
KYX Dispenser, Liquid Medication

GMDN Terms

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

Identifiers

Type ID
Package 20817522013258
Primary 10817522013251
Package 30817522013255
Unit of Use 00817522013254