FDA UDI In Commercial Distribution 🇺🇸 United States

andorate® Air/Water Bottle Tubing with Side Port

DI: 04897106954933 · Model: GAR076US · GA Health Company Limited
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
andorate® Air/Water Bottle Tubing with Side Port
Primary DI
04897106954933
Version / Model
GAR076US
Company Name
GA Health Company Limited
Labeler DUNS
686908512
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-01-13
Public Version
2
Public Version Date
2022-06-10
Public Version Status
Update
Public Device Record Key
2d2edd7f-fca5-48ae-93f0-b7c9f5d91210

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
No
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
OCX Endoscopic Irrigation/Suction System

GMDN Terms

Code Name
60738 Endoscopic insufflation tubing set, single-use

Identifiers

Type ID
Package 14897106954930
Primary 04897106954933
Package 24897106954937