Primary Device ID | 05051968041319 |
NIH Device Record Key | 05341ea9-1a97-462e-8ced-dc940750bca8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DOPPLEX |
Version Model Number | VP10XS-USA |
Catalog Number | VP10XS-USA |
Company DUNS | 217207083 |
Company Name | HUNTLEIGH HEALTHCARE LIMITED |
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 | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 5 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 5 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 5 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 5 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 5 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 5 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 5 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 5 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 5 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 5 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 5 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 5 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 5 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 5 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 5 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 5 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 5 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 5 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05051968041319 [Primary] |
JAF | Monitor, Ultrasonic, Nonfetal |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-02-25 |
Device Publish Date | 2020-02-17 |
05051968032102 | ANTEPARTUM FETAL MONITOR BD4000XS-2/USA |
05051968032089 | ANTEPARTUM MONITOR USA |
05051968032058 | D900 DATASCOPE |
05051968031792 | FM830-SL ENCORE COMPLETE SYSTEM |
05051968031785 | FM820-SL ENCORE COMPLETE SYSTEM |
05051968031761 | DOPPLEX REPORTER DR4 USA UPGRADE |
05051968031747 | DOPPLEX REPORTER DR4 USA |
05051968030542 | DATASCOPE PROBE,8MHZ,CE |
05051968030535 | DATASCOPE D900 C/W VP8 |
05051968030511 | ADULT CUFF SET |
05051968030504 | ADULT LEFT ANKLE CUFF |
05051968030498 | ADULT LEFT ARM CUFF |
05051968030481 | ADULT RIGHT ANKLE CUFF |
05051968030474 | ADULT RIGHT ARM CUFF |
05051968030436 | ROLL SELF ADHSV PAPER PACK(PKD 5) |
05051968030429 | STANDARD PAPER ROLL (PKD 5) |
05051968030412 | ABILITY SLEEVES - BOX OF 100 |
05051968030375 | LARGE ADULT CUFF CUFF SET |
05051968030368 | LARGE ADULT LEFT ANKLE CUFF |
05051968030351 | LARGE ADULT LEFT ARM CUFF |
05051968030344 | LARGE ADULT RIGHT ANKLE CUFF |
05051968030337 | LARGE ADULT RIGHT ARM CUFF |
05051968030054 | FD3-P USA FETAL DOPPLEX |
05051968030047 | FLEXI DOPPLEX POCKET,USA |
05051968030030 | ABILITY/USA PRINTER + BATTERY |
05051968029539 | PROBE,8MHZ,HS |
05051968029454 | PROBE,5MHZ,HS |
05051968029416 | PROBE,4MHZ,HS |
05051968029379 | PROBE,10MHZ,HS |
05051968028266 | BD4000 ULTRASOUND TRANSDUCER |
05051968025265 | SONICAID ONE |
05051968024459 | SUPER DOPPLEX II POCKET,USA |
05051968023070 | PAD SCREENING KIT - USA |
05051968022981 | PROBE ADAPTOR PA8 - HG |
05051968022950 | PROBE,3MHZ,HS |
05051968022912 | PROBE,2MHZ,HS |
05051968022264 | MP1 RECHARGEABLE PRODUCT |
05051968022240 | SMARTSIGNS MINIPULSE |
05051968021281 | MULTI DOPPLEX II POCKET,USA |
05051968020536 | ISP3-USA |
05051968020482 | IPP3-USA |
05051968020161 | INTRAOPERATIVE PROBE 8MHZ - USA |
05051968020154 | IOP8 - DEMO KIT 2 - USA |
05051968019301 | FETAL DOPPLEX II POCKET,USA |
05051968019172 | FETAL DOPPLEX,POCKET,USA |
05051968018496 | PROBE,8MHZ,WIDE BEAM |
05051968018410 | EVENT MARKER |
05051968017666 | DIABETIC FOOT KIT-USA MINI DOPPLX |
05051968017642 | DIA FOOT KIT-USA MULTI DOPLX PLUS |
05051968017277 | AUDIO DOPPLEX POCKET,USA |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DOPPLEX 73523626 1402998 Live/Registered |
HUNTLEIGH TECHNOLOGY, LTD. 1985-02-25 |