FDA.report

BIOTRANS™ Reusable Sensor Base and Monitor Adapter Cables

Primary DI
08886483508330
Company
BIOPTIMAL INTERNATIONAL PTE. LTD.
Model
BT-201 (CAT#5867983)-GE
Catalog number
BL-0003-021
Published
2021-03-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Regulatory Flags

DUNS number
595182247
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
68886483508332PackageGS172In Commercial Distribution
08886483508330PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
68886483508332PackageGS17208886483508330In Commercial Distribution
08886483508330PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
DRSTransducer, Blood-Pressure, Extravascular2Cardiovascular870.2850NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Invasive-pressure external transducer, reusableA noninvasive, non-luminal, electronic device designed to be connected to an appropriate invasive luminal device (e.g., catheter, cannula, tube, needle), to detect pressures (e.g., blood, gastrointestinal, urinary pressures) within the lumen and transmit them as electrical signals to an appropriate monitoring device. It consists of a pressure transducer and a connection cable and may be designed to be used with a pressure transducer dome. This is a reusable device.

Device Sizes

No records found.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in dark cool dry places

Sterilization Methods

Method

Contacts

PhoneEmail
+6562135777Sales_CCP@bioptimalg.com

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08886483501263Thermodilution Catheter and AccessoriesTD1704NX-ARG(497526)21-000117-082020-10-01

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