Reusable NIBP Cuff

GUDID 06970706368114

With inflation bag, Single tube Thigh Range 38-50cm

Orantech Inc.

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• Primary Device ID: 06970706368114
• NIH Device Record Key: 740aa7f2-050f-4d68-9596-f8876888d844
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reusable NIBP Cuff
• Version Model Number: BP-90BS
• Company DUNS: 544423370
• Company Name: Orantech Inc.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970706368114 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173197

FDA Product Code

• DXQ: Blood Pressure Cuff

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-01
• Device Publish Date: 2020-12-24

On-Brand Devices [Reusable NIBP Cuff]

• 06970706368114: With inflation bag, Single tube Thigh Range 38-50cm
• 06970706368107: With inflation bag, Single tube Large Adult Long Range 31-53cm
• 06970706368091: With inflation bag, Single tube Large Adult Range 31-40cm
• 06970706368084: With inflation bag, Single tube Adult Extra Long Range 23-46cm
• 06970706368077: With inflation bag, Single tube Adult Range 23-33cm
• 06970706368060: With inflation bag, Single tube SmallAdult Range 17-25cm
• 06970706368053: With inflation bag, Single tube Child Range 12-19cm
• 06970706368046: With inflation bag, Single tube Infant Range 8-13cm
• 06970706368039: With inflation bag, Single tube Neonatal Range 6-11cm