DOPPLEX ABI-USA
GUDID 05051968041340
USA ANKLE BRACHIAL INDEX KIT
HUNTLEIGH HEALTHCARE LIMITED
Noninvasive vascular ultrasound system, battery-powered| Primary Device ID | 05051968041340 |
| NIH Device Record Key | 2bc4f061-00e8-47a4-8f94-d3ee0e81ef8e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DOPPLEX |
| Version Model Number | ABI-USA |
| Catalog Number | ABI-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 |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Atmospheric Pressure | Between 35 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between -25 Degrees Celsius and 5 Degrees Celsius |
| Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 35 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between -25 Degrees Celsius and 5 Degrees Celsius |
| Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 35 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between -25 Degrees Celsius and 5 Degrees Celsius |
| Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 35 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between -25 Degrees Celsius and 5 Degrees Celsius |
| Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 35 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between -25 Degrees Celsius and 5 Degrees Celsius |
| Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 35 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between -25 Degrees Celsius and 5 Degrees Celsius |
| Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 35 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between -25 Degrees Celsius and 5 Degrees Celsius |
| Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 35 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between -25 Degrees Celsius and 5 Degrees Celsius |
| Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 35 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between -25 Degrees Celsius and 5 Degrees Celsius |
| Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 35 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between -25 Degrees Celsius and 5 Degrees Celsius |
| Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 35 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between -25 Degrees Celsius and 5 Degrees Celsius |
| Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 35 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between -25 Degrees Celsius and 5 Degrees Celsius |
| Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 35 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between -25 Degrees Celsius and 5 Degrees Celsius |
| Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 35 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between -25 Degrees Celsius and 5 Degrees Celsius |
| Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 35 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between -25 Degrees Celsius and 5 Degrees Celsius |
| Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 35 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between -25 Degrees Celsius and 5 Degrees Celsius |
| Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 35 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between -25 Degrees Celsius and 5 Degrees Celsius |
| Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 35 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between -25 Degrees Celsius and 5 Degrees Celsius |
| Storage Environment Humidity | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 35 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05051968041340 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K183574
FDA Product Code
| DPW | Flowmeter, Blood, Cardiovascular |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-27 |
| Device Publish Date | 2020-02-19 |
On-Brand Devices [DOPPLEX]
| 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 |
Trademark Results [DOPPLEX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DOPPLEX 73523626 1402998 Live/Registered |
HUNTLEIGH TECHNOLOGY, LTD. 1985-02-25 |
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