Softcheck DT3544MB
GUDID 10841522108273
BP CUFF,SC FABRIC,2T,LG ADULT LN,35-44CM,MB
Statcorp Medical
Blood pressure cuff, single-use| Primary Device ID | 10841522108273 |
| NIH Device Record Key | ed2733cf-b143-4926-9ebd-0c542cd94ba3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Softcheck |
| Version Model Number | SoftCheck BP Cuffs |
| Catalog Number | DT3544MB |
| 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 | true |
| 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 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 |
| 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 | 10841522108273 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K940214
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 | 2023-08-18 |
| Device Publish Date | 2016-10-24 |
On-Brand Devices [Softcheck]
| 10841522122125 | BP CUFF, PHYSIO, SC FABRIC, 1T, SM ADULT, HP, EA |
| 10841522119408 | BP CUFF,SC FABRIC,2T,LG.ADULT,32-42CM,DM,EA |
| 10841522116087 | BP CUFF,SC FREE NEO,2T,SIZE 1,3-6CM,ML,EA |
| 10841522112041 | BP CUFF,SC FABRIC,1T,INFANT,8-14CM,FL,EA |
| 10841522111952 | BP CUFF,SC FABRIC,2T,LG.ADULT,32-42CM,NF,EA |
| 10841522111372 | BP CUFF,SC FABRIC,1T,LG.ADULT-L,35-44CM,MQML,EA |
| 10841522111365 | BP CUFF,SC FABRIC,1T,THIGH,42-50CM,MQML,EA |
| 10841522111341 | BP CUFF,SC FABRIC,1T,LG.ADULT,32-42CM,MQML,EA |
| 30841522111314 | BP CUFF,SC FABRIC,1T,ADULT-LNG,29-38CM,MQML,EA |
| 30841522111291 | BP CUFF,SC FABRIC,1T,ADULT,26-35CM,MQML,EA |
| 10841522111273 | BP CUFF,SC FABRIC,1T,SM.ADULT,18-26CM,MQML,EA |
| 10841522111242 | BP CUFF,SC FABRIC,1T,CHILD,13-20CM,MQML,EA |
| 10841522111228 | BP CUFF,SC FABRIC,1T,INFANT,8-14CM,MQML,EA |
| 10841522109645 | BP CUFF,SC FABRIC,1T,THIGH,42-50CM,ML |
| 10841522109607 | BP CUFF,SC FABRIC,1T,THIGH,42-50CM,DM |
| 30841522109533 | BP CUFF,SC FABRIC,1T,LG.ADULT-L,35-44CM,HP,EA |
| 10841522109522 | BP CUFF,SC FABRIC,1T,LG.ADULT-L,35-44CM,DM |
| 30841522109458 | BP CUFF,SC FABRIC,1T,LG.ADULT,32-42CM,HP, EA |
| 10841522109379 | BP CUFF,SC FABRIC,1T,ADULT-LONG,29-38CM,ML |
| 30841522109342 | BP CUFF,SC FABRIC,1T,ADULT-LONG,29-38CM,HP,EA |
| 10841522109324 | BP CUFF,SC FABRIC,1T,ADULT-LONG,29-38CM,FL,EA |
| 10841522109263 | BP CUFF,SC FABRIC,1T,ADULT,26-35CM,ML |
| 10841522109218 | BP CUFF,SC FABRIC,1T,ADULT,26-35CM,FL,EA |
| 10841522109157 | BP CUFF,SC FABRIC,1T,SM.ADULT,18-26CM,ML |
| 50841522109124 | BP CUFF,SC FABRIC,1T,SM.ADULT,18-26CM,HP,EA |
| 10841522109102 | BP CUFF,SC FABRIC,1T,SM.ADULT,18-26CM,FL,EA |
| 10841522109041 | BP CUFF,SC FABRIC,1T,CHILD,13-20CM,ML |
| 10841522109034 | SOFTCHECK ADULT DOUBLE TUBE WITH 16" TUBE |
| 10841522109027 | BP CUFF,SC FABRIC,1T-16IN,ADULT,26-35CM |
| 10841522109003 | BP CUFF,SC FABRIC,1T,CHILD,13-20CM,DM |
| 10841522108990 | BP CUFF,SC FABRIC,1T,CHILD,13-20CM,FL, EA |
| 10841522108952 | BP CUFF,SC FABRIC,1T,LG.ADULT-L,35-44CM,ML |
| 10841522108945 | BP CUFF,SC FABRIC,2T,LG ADULT,32-42CM,MBDM |
| 10841522108938 | BP CUFF,SC FABRIC,1T,INFANT,8-14CM,ML |
| 10841522108921 | BP CUFF,SC FABRIC,2T,LG ADULT,32-42CM,MB5 |
| 10841522108914 | BP CUFF,SC FABRIC,2T,ADULT-LONG,29-38CM,MB 5FT |
| 30841522108901 | BP CUFF,SC FABRIC,1T,INFANT,8-14CM,HP,EA |
| 10841522108891 | BP CUFF,SC FABRIC,1T,INFANT,8-14CM,DM |
| 10841522108334 | BP CUFF,SC FABRIC,2T,CHILD,26-35CM,MBDM |
| 10841522108273 | BP CUFF,SC FABRIC,2T,LG ADULT LN,35-44CM,MB |
| 10841522108259 | BP CUFF,SC FABRIC,2T,LG ADULT,32-42CM,MB |
| 10841522108235 | BP CUFF,SC FABRIC,2T,ADULT LONG,29-38CM,MB, EA |
| 10841522107634 | BP CUFF,SC FABRIC,2T,LG.ADULT-L,35-44CM,MQMF |
| 10841522107603 | BP CUFF,SC FABRIC,2T,LG.ADULT-L,35-44CM,MQ,EA |
| 10841522107573 | BP CUFF,SC FABRIC,2T,LG.ADLT-L,35-44CM,DM,EA |
| 10841522107559 | BP CUFF,SC FABRIC,2T,LG.ADULT,32-42CM,MQMF |
| 50841522107526 | BP CUFF,SC FABRIC,2T,LG.ADULT,32-42CM,MQ,EA |
| 10841522107504 | BP CUFF,SC FABRIC,2T,ADULT-LONG,29-38CM,MQMF |
| 30841522107478 | BP CUFF,SC FABRIC,2T,ADULT-LONG,29-38CM,MQ,EA |
| 50841522107427 | BP CUFF,SC FABRIC,2T,ADULT,26-35CM,MQ, EA |
Trademark Results [Softcheck]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOFTCHECK 78117218 2666695 Live/Registered |
Faro Technologies, Inc. 2002-03-25 |
 SOFTCHECK 76672357 3315409 Live/Registered |
SPACELABS HOLDINGS, INC. 2007-02-05 |
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