FDA UDI In Commercial Distribution 🇺🇸 United States

Air/Water Bottle Tubing with Side Port (for US Market)

DI: 04897106954117 · Model: EN10902B · 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
Air/Water Bottle Tubing with Side Port (for US Market)
Primary DI
04897106954117
Version / Model
EN10902B
Company Name
GA Health Company Limited
Labeler DUNS
686908512
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-01-31
Public Version
3
Public Version Date
2023-03-23
Public Version Status
Update
Public Device Record Key
c59024bb-ebde-4b37-aa0b-27ad5cebc8d5

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 14897106954114
Primary 04897106954117
Package 24897106954111