FDA UDI In Commercial Distribution 🇺🇸 United States

andorate® Air/Water Bottle Tubing with CO2 Extend

DI: 04897106950041 · Model: GAR025CO2EXTUS · GA Health Company Limited
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

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Basic Information

Brand Name
andorate® Air/Water Bottle Tubing with CO2 Extend
Primary DI
04897106950041
Version / Model
GAR025CO2EXTUS
Company Name
GA Health Company Limited
Labeler DUNS
686908512
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-05-28
Public Version
4
Public Version Date
2022-06-10
Public Version Status
Update
Public Device Record Key
8d36d1a7-0745-41a4-bdeb-c57a41ceb3f5

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
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 14897106950048
Primary 04897106950041
Package 24897106950045