Statcorp Medical 016-1826-02

GUDID 10841522128516

BP CUFF, UC ABP NYLON, SM ADULT, 18-26CM, EA

STATCORP MEDICAL

Blood pressure cuff, reusable

• Primary Device ID: 10841522128516
• NIH Device Record Key: d99bbab3-bbf1-4fc1-9453-0f5acc681624
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Statcorp Medical
• Version Model Number: STATCORP
• Catalog Number: 016-1826-02
• Company DUNS: 038942055
• 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

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Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841522128516 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152801

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: 7
• Public Version Date: 2020-05-01
• Device Publish Date: 2019-08-19

On-Brand Devices [Statcorp Medical]

• 50841522111806: BP CUFF,SC VINYL,1T,ADULT,26-35CM,MQ,20/BX
• 50841522111776: BP CUFF,SC VINYL,1T,ADULT,26-35CM,ML,20/BX
• 50841522111554: BP CUFF,SC VINYL,1T,CHILD,13-20CM,MQ,20/BX
• 50841522111493: Statcorp Non-Invasive Blood Pressure Cuffs and Accessories
• 50841522111417: BP CUFF,SC VINYL,1T,INFANT,8-14CM,MQ,20/BX
• 50841522109667: BP CUFF,SC FABRIC,1T,THIGH,42-50CM,MQ,20/BX
• 50841522109568: BP CUFF,SC FABRIC,1T,LG.ADULT-L,35-44CM,MQ,20/BX
• 50841522109483: BP CUFF,SC FABRIC,1T,LG.ADULT,32-42CM,MQ,20/BX
• 50841522109407: BP CUFF,SC FABRIC,1T,ADULT-LONG,29-38CM,MQ,20/BX
• 50841522109292: BP CUFF,SC FABRIC,1T,ADULT,26-35CM,MQ,20/BX
• 50841522109186: BP CUFF,SC FABRIC,1T,SM.ADULT,18-26CM,MQ,20/BX
• 50841522109070: BP CUFF,SC FABRIC,1T,CHILD,13-20CM,MQ,20/BX
• 50841522108967: BP CUFF,SC FABRIC,1T,INFANT,8-14CM,MQ,20/BX
• 30841522111802: BP CUFF,SC VINYL,1T,ADULT,26-35CM,MQ,5/BG
• 30841522111772: BP CUFF,SC VINYL,1T,ADULT,26-35CM,ML,5/BG
• 30841522111697: Statcorp Non-Invasive Blood Pressure Cuffs and Accessories
• 30841522111550: BP CUFF,SC VINYL,1T,CHILD,13-20CM,MQ,5/BG
• 30841522111413: BP CUFF,SC VINYL,1T,INFANT,8-14CM,MQ,5/BG
• 30841522111338: BP CUFF,SC VINYL NEO,1T,SIZE 5,8-15CM,MQ,10/BX
• 30841522111307: BP CUFF,SC VINYL NEO,1T,SIZE 5,8-15CM,ML,10/BX
• 30841522111260: BP CUFF,SC VINYL NEO,1T,SIZE 4,7-13CM,MQ,10/BX
• 30841522111239: BP CUFF,SC VINYL NEO,1T,SIZE 4,7-13CM,ML,10/BX
• 30841522111192: BP CUFF,SC VINYL NEO,1T,SIZE 3,6-11CM,MQ,10/BX
• 30841522111161: Statcorp Non-Invasive Blood Pressure Cuffs and Accessories
• 30841522111123: Statcorp Non-Invasive Blood Pressure Cuffs and Accessories
• 30841522111093: BP CUFF,SC VINYL NEO,1T,SIZE 2,4-8CM,ML,10/BX
• 30841522111055: Statcorp Non-Invasive Blood Pressure Cuffs and Accessories
• 30841522111024: BP CUFF,SC VINYL NEO,1T,SIZE 1,3-6CM,ML,10/BX
• 30841522110966: BP CUFF,UC NYLON,1T,THIGH,42-50CM,MHP,5/BG
• 30841522110904: BP CUFF,UC NYLON,1T,THIGH,42-50CM,NF,5/BG
• 30841522110843: BP CUFF,UC NYLON,1T,LG.ADULT-L,35-44CM,MHP,5/BG
• 30841522110720: BP CUFF,UC NYLON,1T,LG.ADULT,32-42CM,NF,5/BG
• 30841522110669: BP CUFF,UC NYLON,1T,ADULT LONG,29-38CM,MHP,5/BG
• 30841522110607: BP CUFF,UC NYLON,1T,ADULT LONG,29-38CM,NF,5/BG
• 30841522110584: BP CUFF,UC NYLON,1T,CHILD,26-35CM,MQML,5/BG
• 30841522110546: BP CUFF,UC NYLON,1T,ADULT,26-35CM,MHP,5/BG
• 30841522110461: BP CUFF,UC NYLON,1T,SM.ADULT,18-26CM,MHP,5/BG
• 30841522110362: BP CUFF,UC NYLON,1T,CHILD,13-20CM,MHP,5/BG
• 30841522110287: BP CUFF,UC NYLON,1T,INFANT,8-14CM,MHP,5/BG
• 30841522110263: Statcorp Non-Invasive Blood Pressure Cuffs and Accessories
• 30841522110225: BP CUFF,UC NYLON,2T,THIGH,42-50CM,MQ,5/BG
• 30841522110140: BP CUFF,UC NYLON,2T,LG.ADULT-L,35-44CM,MQ,5/BG
• 30841522110065: BP CUFF,UC NYLON,2T,LG.ADULT,32-42CM,MQ,5/BG
• 30841522110003: BP CUFF,UC NYLON,2T,ADULT-LONG,29-38CM,MQ,5/BG
• 30841522109984: BP CUFF,UC NYLON,2T,ADULT-LONG,29-38CM,MB,5/BG
• 30841522109953: BP CUFF,UC NYLON,2T,ADULT,26-35CM,MQ,5/BG
• 30841522109892: BP CUFF,UC NYLON,2T,SM.ADULT,18-26CM,MQ,5/BG
• 30841522109809: BP CUFF,UC NYLON,2T,CHILD,13-20CM,MQ,5/BG
• 30841522109663: BP CUFF,SC FABRIC,1T,THIGH,42-50CM,MQ,5/BG
• 30841522109649: BP CUFF,SC FABRIC,1T,THIGH,42-50CM,ML,5/BG