FDA UDI Not in Commercial Distribution 🇺🇸 United States

PUGGLE™ G-Tube

DI: 00704411007282 · Model: 1 · AMSINO INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
PUGGLE™ G-Tube
Primary DI
00704411007282
Version / Model
1
Catalog Number
PLG16-10
Company Name
AMSINO INTERNATIONAL, INC.
Labeler DUNS
825673239
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-05-10
Public Version
2
Public Version Date
2018-09-20
Public Version Status
Update
Public Device Record Key
98da1ff9-7d26-43a6-ab58-2cdc347fbbd3
Distribution End Date
2018-09-20

Device Description

PUGGLE™ G-Tube 16 Fr. 10 mL GASTROSTOMY TUBE WITH Y-PORTS

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 30704411007283
Package 40704411007280
Primary 00704411007282