Ultracheck US2635FL
GUDID 10841522110504
BP CUFF,UC NYLON,1T,ADULT,26-35CM,FL,EA
Statcorp Medical
Blood pressure cuff, reusable| Primary Device ID | 10841522110504 |
| NIH Device Record Key | da2b5e4f-eae3-4900-a2d0-300b0adbc7eb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ultracheck |
| Version Model Number | UltraCheck BP Cuffs |
| Catalog Number | US2635FL |
| 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 |
| 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 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 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 | 10841522110504 [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 | 9 |
| Public Version Date | 2023-08-18 |
| Device Publish Date | 2016-10-19 |
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 |
| 10841522110740 | BP CUFF,UC NYLON,1T,LG.ADULT,32-42CM,FL,EA |
| 10841522130717 | BP CUFF,PHYSIO,UC FABRIC, 1T,LG ADULT LNG,HP,EA |
| 10841522130694 | BP CUFF, PHYSIO, UC FABRIC, 1T, LG ADULT, HP, EA |
| 10841522130663 | BP CUFF,PHYSIO,UC,1T,ADULT,MHP,EA |
| 10841522130625 | BP CUFF, PHYSIO, UC FABRIC, 1T, CHILD, HP, EA |
| 10841522130588 | BP CUFF, PHYSIO, UC FABRIC, 1T, INFANT, HP, EA |
| 10841522128592 | BP CUFF, UC CURVE,2T,XL.ADULT,38-54CM,MB,EA |
Trademark Results [Ultracheck]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ULTRACHECK 77368200 3556312 Live/Registered |
AGILENT TECHNOLOGIES, INC. 2008-01-10 |
 ULTRACHECK 75202172 2241028 Dead/Cancelled |
Compagnie Plastic Omnium 1996-11-14 |
 ULTRACHECK 75000925 2292982 Live/Registered |
SPACELABS HOLDINGS, INC. 1995-10-03 |
 ULTRACHECK 74580324 1992447 Dead/Cancelled |
ULTRA Scientific, Incorporated 1994-09-29 |
 ULTRACHECK 74306558 1781916 Live/Registered |
AREVA INC 1992-08-24 |
 ULTRACHECK 74271418 1748267 Live/Registered |
AREVA INC 1992-05-01 |
 ULTRACHECK 74271417 1751105 Dead/Cancelled |
FRAMATOME ANP, INC. 1992-05-01 |
 ULTRACHECK 74003126 1612793 Dead/Cancelled |
KRONES AKTIENGESELLSCHAFT HERMANN KRONSEDER MASCHINENFABRIK 1989-11-17 |
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