BIOTRANS™ Pressure Monitoring Kits 22-000074-10

GUDID 08886483501829

BIOPTIMAL INTERNATIONAL PTE. LTD.

Invasive blood pressure transducer set

• Primary Device ID: 08886483501829
• NIH Device Record Key: 1479f167-0056-44c4-8477-ebbbdfe85fe7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOTRANS™ Pressure Monitoring Kits
• Version Model Number: PT24(BNS)-USA
• Catalog Number: 22-000074-10
• Company DUNS: 595182247
• Company Name: BIOPTIMAL INTERNATIONAL PTE. LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08886483501829 [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: 2023-11-08
• Device Publish Date: 2023-10-31

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