FDA.report

BIOTRANS™ Pressure Monitoring Kits

Primary DI
08886483502949
Company
BIOPTIMAL INTERNATIONAL PTE. LTD.
Model
MED-LOC LOCKING CANNULA-USA
Catalog number
22-000895-55
Published
2023-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
false
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
08886483502949PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
08886483502949PrimaryGS10

Product Codes

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

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Invasive blood pressure transducer setA collection of devices that includes tubing, a pressure transducer(s), and other items [e.g., connectors, stopcock(s), clamps and filters] intended to be used for an invasive blood pressure measurement. This set will typically connect directly to the applied invasive catheter and the transducer will provide the electrical signals for display by a patient monitoring system. This device will have physical characteristics appropriate for preserving, to the extent possible, the waveform and fidelity of the measured pressure. This is a single-use device.

Device Sizes

No records found.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in dark cool dry places.

Sterilization Methods

Method

Contacts

No records found.

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08886483500686Thermodilution Catheter and AccessoriesTD2755NX-CCF21-000050-702020-10-01
08886483500761Thermodilution Catheter and AccessoriesTD2755NDFX-BSI21-000050-922020-10-01
08886483501232Thermodilution Catheter and AccessoriesTD1755ND-ARG(497520)21-000116-082020-10-01
08886483501249Thermodilution Catheter and AccessoriesTD1755NSD-ARG(497531)21-000116-092020-10-01
08886483501256Thermodilution Catheter and AccessoriesTD1704ND-ARG(497521)21-000117-072020-10-01
08886483501263Thermodilution Catheter and AccessoriesTD1704NX-ARG(497526)21-000117-082020-10-01

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