Ultracheck US3544MML

GUDID 10841522109362

UC LARGE ADULT LONG SINGLE TUBE, MML

Statcorp Medical

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• Primary Device ID: 10841522109362
• NIH Device Record Key: 9def9818-2994-42dc-bacf-24255613154e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultracheck
• Version Model Number: UltraCheck BP Cuffs
• Catalog Number: US3544MML
• Company DUNS: 602075905
• Company Name: Statcorp Medical
• 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841522109362 [Primary]

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: 5
• Public Version Date: 2023-10-25
• Device Publish Date: 2016-10-24

On-Brand Devices [Ultracheck]

• 10841522122118: BP CUFF, PHYSIO, UC FABRIC, 1T, SM ADULT, HP, EA
• 10841522110689: BP CUFF,UC NYLON,1T,ADULT LONG,29-38CM,ML,EA
• 10841522110627: BP CUFF,UC NYLON,1T,ADULT LONG,29-38CM,FL,EA
• 10841522110566: BP CUFF,UC NYLON,1T,ADULT,26-35CM,ML,EA
• 10841522110504: BP CUFF,UC NYLON,1T,ADULT,26-35CM,FL,EA
• 10841522110481: BP CUFF,UC NYLON,1T,SM.ADULT,18-26CM,ML,EA
• 10841522110429: BP CUFF,UC NYLON,1T,SMALL ADULT,18-26CM,FL,EA
• 10841522110320: BP CUFF,UC NYLON,1T,CHILD,13-20CM,FL,EA
• 10841522110115: BP CUFF,UC NYLON,2T,LG.ADULT-L,35-44CM,HP
• 10841522110078: BP CUFF,UC NYLON,2T,LG.ADULT,32-42CM,HP
• 10841522109775: BP CUFF,UC NYLON,2T,CHILD,13-20CM,HP
• 10841522109287: ULTRACHECK SMALL ADULT SINGLE TUBE, MML
• 10841522109256: ULTRACHECK INFANT SINGLE TUBE, MML
• 10841522109065: BP CUFF,UC NYLON,2T-16IN,THIGH,42-50CM,NF
• 10841522109058: BP CUFF,UC NYLON,2T-16IN,ADULT,26-35CM,NF
• 10841522106651: BP CUFF,UC NYLON,1T-16IN,LG.AD,32-42CM,NF,EA
• 10841522110863: BP CUFF,UC NYLON,1T,LG.ADULT-L,35-44CM,ML,EA
• 10841522110801: BP CUFF,UC NYLON,1T,LG.ADULT-L,35-44CM,FL,EA
• 10841522109386: ULTRACHECK THIGH SINGLETUBE, MML
• 10841522109362: UC LARGE ADULT LONG SINGLE TUBE, MML
• 10841522109355: ULTRACHECK LARGE ADULT SINGLE TUBE, MML