FDA UDI In Commercial Distribution 🇺🇸 United States

BIOTRANS™ Reusable Sensor Base and Monitor Adapter Cables

DI: 08888893501321 · Model: CM-BT201 (MEDTRANS II) · BIOPTIMAL INTERNATIONAL PTE. LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
BIOTRANS™ Reusable Sensor Base and Monitor Adapter Cables
Primary DI
08888893501321
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
2016-09-01
Public Version
4
Public Version Date
2020-06-30
Public Version Status
Update
Public Device Record Key
f3aa009e-1d5e-4df3-86ca-bca799fa2021

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
Package 68888893501323
Primary 08888893501321

Customer Contacts

Phone
+6562135777

Storage Conditions

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