FDA UDI In Commercial Distribution 🇺🇸 United States

N/A

DI: 26923980108840 · Model: AB0090 · GaleMed Xiamen Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

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Basic Information

Brand Name
N/A
Primary DI
26923980108840
Version / Model
AB0090
Company Name
GaleMed Xiamen Co., Ltd.
Labeler DUNS
527333326
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-05-27
Public Version
2
Public Version Date
2025-05-22
Public Version Status
Update
Public Device Record Key
5b312e04-3a3f-42cc-8f84-16a5040ceaec

Device Description

Silicone J-Circuit, Adult

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)

GMDN Terms

Code Name
37705 Ventilator breathing circuit, reusable

Identifiers

Type ID
Package 46923980108844
Primary 26923980108840