BIOTRANS™ Pressure Monitoring Kits 22-000895-80

GUDID 08886483503038

BIOPTIMAL INTERNATIONAL PTE. LTD.

Invasive blood pressure transducer set

• Primary Device ID: 08886483503038
• NIH Device Record Key: c1713da6-fd0c-4d41-a17b-c2d40a3c00a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOTRANS™ Pressure Monitoring Kits
• Version Model Number: BTR-6012-MV (VA SLC)
• Catalog Number: 22-000895-80
• Company DUNS: 595182247
• Company Name: BIOPTIMAL INTERNATIONAL PTE. LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com
• Phone: +6562135777
• Email: Sales_CCP@biosensors.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in dark cool dry places
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark cool dry places
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark cool dry places
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark cool dry places
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark cool dry places
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark cool dry places
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark cool dry places
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark cool dry places
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark cool dry places
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark cool dry places
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark cool dry places
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark cool dry places

Device Identifiers

Device Issuing Agency	Device ID
GS1	08886483503038 [Primary]

FDA Product Code

• DRS: Transducer, Blood-Pressure, Extravascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-09
• Device Publish Date: 2020-10-01

On-Brand Devices [BIOTRANS™ Pressure Monitoring Kits]

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• 98888893314023: BTR-3 W/O IFU-BULK PACK (NON-STERILE)
• 98888893313835: LS2 ADD-ON KIT-USA
• 98888893313828: BTR-30 (N/S & BULK PACK)-CARDIOMED
• 98888893313552: BTR60-40DL KIT (USA)
• 98888893313521: MED-LOC LOCKING CANNULA-USA
• 98888893313187: BTR-3-91077 McALLEN CV KIT
• 98888893312272: SBC-3 CANNULA LL WITH 3CC SYRINGE (USA)
• 98888893311565: 91065 NICU KIT - CHILDREN'S MERCY HOSPI
• 98888893311541: 91063 DUAL PRESSURE KIT - CHILDREN'S MER
• 98888893311534: 91062 SINGLE LINE KIT - CHILDREN'S MERCY
• 98888893311503: NORFOLK CHILDRENS ARTERIAL LINE SET
• 98888893311367: CCF-ICU ADD-ON KIT-CC91038
• 98888893311350: CCF-ICU TRIFURCATED KIT-CC91037
• 98888893311268: CCF-STD SGL LINE MEAN SET-CC91021
• 98888893311213: CCF-MEAN SET-CC91016
• 98888893311206: CCF-QUAD CUSTOM SET-CC91015
• 98888893311190: CCF-TRIFURCATED SGL LINE SET-CC91014
• 98888893311183: CCF-SINGLE LINE ADD-ON SET-CC91013
• 98888893311169: CCF-SWAN SET-CC91011
• 98888893311152: CCF-LEFT HEART SET-CC91010
• 98888893311008: BTR-2448-3-BP2 (USA)
• 98888893310940: BTR 6012-3 DL (USA)
• 98888893310926: COVERED NEEDLELESS CANNULA (USA)
• 98888893310902: BTR1 (USA)
• 98888893310896: BTR3-6012-3 (USA)
• 98888893310889: BTR2-6012-3 (USA)
• 98888893310858: BTR BIOTRANS DOME W/O FLUSH DEVICE(USA)
• 98888893310841: BTR 6012-3(USA)
• 98888893310834: BTR-3(USA)
• 98888893310810: BTR 24-40(USA)
• 98888893309173: PT-36
• 98888893309166: PT-72
• 98888893309159: PT-60
• 98888893309142: PT-48
• 98888893305991: CCF-CARDIO ICU TRI-FUR KIT CC91039
• 98888893305984: BTR3-4812-3-BP2-S (USA)
• 98888893305441: PT06
• 98888893305182: 3-WAY STOPCOCK WHITE PKG
• 98888893304772: PT24
• 98888893303270: PT12
• 98888893019485: PT24 (BNS-W/O LABEL)-USA
• 98888893019478: PT06 (BNS-W/O LABEL)-USA
• 98888893019461: PT06M (BNS-W/O LABEL)-USA
• 98888893019454: PT72M (BNS-W/O LABEL)-USA
• 98888893019447: PT12 (BNS-W/O LABEL)-USA
• 98888893013094: EXTENSION TUBING SET (CCF)
• 98888893012851: BTR40 LS2-S (USA)
• 98888893012837: BP3-LS3-S ADD-ON KIT(USA)