Blood Pressure Cuff

GUDID 00815871022651

INFANT CUFF SINGLE LUMEN LATEX FREE, CUFF SIZE 7.8-13.5 CM

Avante

Blood pressure cuff, reusable

• Primary Device ID: 00815871022651
• NIH Device Record Key: 1f2be4d2-bfd6-410c-8f3a-4a184826c33e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blood Pressure Cuff
• Version Model Number: 80031-I
• Company DUNS: 178440426
• Company Name: Avante
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815871022651 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143728

FDA Product Code

• DXQ: Blood Pressure Cuff

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-22
• Device Publish Date: 2017-06-20

On-Brand Devices [Blood Pressure Cuff]

• 00815871022750: NIBP Single Tube Bladder Cuff, Adult Extra Long 25-35 CM
• 00815871022743: NIBP Single Tube Bladder Cuff, Large Adult Long 33-47 CM
• 00815871022675: CUFF NEONATE
• 00815871022668: CHILD CUFF DUAL LUMEN LATEX FREE, CUFF SIZE 13-21 CM
• 00815871022651: INFANT CUFF SINGLE LUMEN LATEX FREE, CUFF SIZE 7.8-13.5 CM
• 00815871022644: INFANT CUFF DUAL LUMEN LATEX FREE, CUFF SIZE 7.8-13.5 CM
• 00815871022552: THIGH SINGLE LUMEN 41-54CM
• 00815871022545: THIGH DUAL LUMEN 41-54CM
• 00815871022538: SMALL ADULT SINGLE LUMEN 20-28CM
• 00815871022521: SMALL ADULT DUAL LUMEN 20-28CM
• 00815871022514: LARGE ADULT SINGLE LUMEN 34-42CM
• 00815871022507: LARGE ADULT CUFF DUAL LUMEN/LATEX FREE CUFF SIZE 34-42 CM
• 00815871022491: CHILD SINGLE LUMEN 13-21CM
• 00815871022484: ADULT SINGLE LUMEN 27-35CM
• 00815871022477: ADULT DUAL LUMEN 27-35CM
• 00815871022460: ADULT SINGLE LUMEN 27-35CM