FDA UDI In Commercial Distribution 🇺🇸 United States

TBG2

DI: 00886333622610 · Model: 682261 · ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
TBG2
Primary DI
00886333622610
Version / Model
682261
Catalog Number
682261
Company Name
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Labeler DUNS
595138793
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-24
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
f6e2fe1a-16a4-495a-84aa-951b9601b377

Device Description

transducer holder with Mid lines for the non flushing and flushing type transducers. It also include a Label Set

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
Yes
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
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
DXN System, Measurement, Blood-Pressure, Non-Invasive

GMDN Terms

Code Name
35504 Blood pressure transducer holder

Identifiers

Type ID
Package 50886333622615
Primary 00886333622610

Customer Contacts