FDA UDI Not in Commercial Distribution 🇺🇸 United States

andorate® Disposable Endoscope Valves Set

DI: 04897106950232 · Model: GAR004C · GA Health Company Limited
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Let the assistant research this device

The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

Free to try · every answer cites its records

Basic Information

Brand Name
andorate® Disposable Endoscope Valves Set
Primary DI
04897106950232
Version / Model
GAR004C
Company Name
GA Health Company Limited
Labeler DUNS
686908512
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-05-28
Public Version
3
Public Version Date
2024-08-08
Public Version Status
Update
Public Device Record Key
fb9cac8e-c999-49d2-9ac8-7435bdd3e701
Distribution End Date
2022-11-08

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
OCX Endoscopic Irrigation/Suction System

GMDN Terms

Code Name
60760 Endoscope channel support kit

Identifiers

Type ID
Package 14897106950239
Primary 04897106950232
Package 24897106950236