STATCORP MEDICAL 712-0931-00

GUDID 30841522121672

NIBP,CUFF,1TB,LG.ADULT-LONG,31-40CM,VINYL

SPACELABS HEALTHCARE (WASHINGTON), INC

Blood pressure cuff, reusable

• Primary Device ID: 30841522121672
• NIH Device Record Key: e6cffd04-983b-4e8a-915d-3c5daefeb1fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STATCORP MEDICAL
• Version Model Number: STATCORP
• Catalog Number: 712-0931-00
• Company DUNS: 145581588
• Company Name: SPACELABS HEALTHCARE (WASHINGTON), 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841522121678 [Primary]
GS1	30841522121672 [Package]; Contains: 10841522121678; Package: PK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954282

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: 6
• Public Version Date: 2019-07-22
• Device Publish Date: 2017-03-14

On-Brand Devices [STATCORP MEDICAL]

• 30841522121672: NIBP,CUFF,1TB,LG.ADULT-LONG,31-40CM,VINYL
• 30841522103951: ABP CUFF,SPACELABS,1T,SMALL ADULT,SINGLE
• 10841522121678: NIBP,CUFF,1TB,LG.ADULT-LONG,31-40CM,VINYL