Inline Sensor Assembly and Inline Temperature Sensor CA-0001-001

GUDID 98888893019515

BIOPTIMAL INTERNATIONAL PTE. LTD.

Pulmonary artery catheter, thermal dilution
Primary Device ID98888893019515
NIH Device Record Key66670dc4-65a6-49be-ad66-46ecf3dc88ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameInline Sensor Assembly and Inline Temperature Sensor
Version Model NumberINLINE TEMPERATURE SENSOR (ILS-1)
Catalog NumberCA-0001-001
Company DUNS595182247
Company NameBIOPTIMAL INTERNATIONAL PTE. LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com
Phone+6562135777
EmailSales_CCP@biosensors.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places

Device Identifiers

Device Issuing AgencyDevice ID
GS108888893019512 [Primary]
GS198888893019515 [Package]
Contains: 08888893019512
Package: PULK PACK [50 Units]
In Commercial Distribution

FDA Product Code

DQOCatheter, Intravascular, Diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[98888893019515]

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[98888893019515]

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[98888893019515]

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[98888893019515]

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[98888893019515]

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[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


[98888893019515]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-06-30
Device Publish Date2016-09-01

On-Brand Devices [Inline Sensor Assembly and Inline Temperature Sensor]

98888893019515INLINE TEMPERATURE SENSOR (ILS-1)
08886483507432INLINE TEMPERATURE SENSOR (ILS-1)

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