DuraCheck

GUDID 20889483631628

DuraCheck Reusable Blood Pressure Cuff Adult

SALTER LABS

Blood pressure cuff, single-use

• Primary Device ID: 20889483631628
• NIH Device Record Key: 0959d30e-7f97-4182-a249-1d6769bbad4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DuraCheck
• Version Model Number: ZDC4201HP-10
• Company DUNS: 022721133
• Company Name: SALTER LABS
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889483631621 [Primary]
GS1	20889483631628 [Package]; Contains: 10889483631621; Package: Box [10 Units]; In Commercial Distribution
GS1	30889483631625 [Package]; Package: Case [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080366

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: 2024-12-09
• Device Publish Date: 2024-11-29

On-Brand Devices [DuraCheck]

• 20889483631666: DuraCheck Reusable Blood Pressure Cuff Thigh
• 20889483631659: DuraCheck Reusable Blood Pressure Cuff Large Adult Long
• 20889483631642: DuraCheck Reusable Blood Pressure Cuff Large Adult
• 20889483631635: DuraCheck Reusable Blood Pressure Cuff Adult Long
• 20889483631628: DuraCheck Reusable Blood Pressure Cuff Adult
• 20889483631611: DuraCheck Reusable Blood Pressure Cuff Small Adult
• 20889483631604: DuraCheck Reusable Blood Pressure Cuff Child