FDA UDI In Commercial Distribution 🇺🇸 United States

BIOTRANS™ Reusable Sensor Base and Monitor Adapter Cables

DI: 08886483506954 · Model: CM-BT201 (MEDTRANS II) · BIOPTIMAL INTERNATIONAL PTE. LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
BIOTRANS™ Reusable Sensor Base and Monitor Adapter Cables
Primary DI
08886483506954
Version / Model
CM-BT201 (MEDTRANS II)
Catalog Number
BL-0003-008
Company Name
BIOPTIMAL INTERNATIONAL PTE. LTD.
Labeler DUNS
595182247
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-10-01
Public Version
1
Public Version Date
2020-10-09
Public Version Status
New
Public Device Record Key
7c44f4f3-dffa-4c82-a1d8-b74e591d7049

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
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
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
DRS Transducer, Blood-Pressure, Extravascular

GMDN Terms

Code Name
14119 Invasive-pressure external transducer, reusable

Identifiers

Type ID
Primary 08886483506954

Customer Contacts

Phone
+6562135777

Storage Conditions

Type
Special Storage Condition, Specify
Special Conditions
Store in dark cool dry places