No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 05051968035370 | DA100P | DA100P-USA | ABILITY-USA + PRINTER | JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 2 | DOPPLEX |
2 | 05051968044501 | VP8XS-USA-DATA | VP8XS-USA-DATA | HIGH SENSITIVITY 8MHZ VASCULAR PROBE | JAF | Monitor, Ultrasonic, Nonfetal | 2 | DOPPLEX |
3 | 05051968041852 | DISP10XS | DISP10XS | DIOP8 PROBE PK + PA8XS + POLE CLAMP | ITX | Transducer, Ultrasonic, Diagnostic | 2 | DOPPLEX |
4 | 05051968041388 | ISP3XS-USA | ISP3XS-USA | USA DMX IOP PROBE STARTER PACK | ITX | Transducer, Ultrasonic, Diagnostic | 2 | DOPPLEX |
5 | 05051968041371 | IOP8-DK3-USA | IOP8-DK3-USA | IOP8-DK3-USA DMX | ITX | Transducer, Ultrasonic, Diagnostic | 2 | DOPPLEX |
6 | 05051968041364 | DMX-USA | DMX-USA | USA VAS WAVEFORM DOPPLER | DPW | Flowmeter, Blood, Cardiovascular | 2 | DOPPLEX |
7 | 05051968041357 | ATP-USA | ATP-USA | USA ANKLE AND TOE PRESSURE KIT | DPW | Flowmeter, Blood, Cardiovascular | 2 | DOPPLEX |
8 | 05051968041340 | ABI-USA | ABI-USA | USA ANKLE BRACHIAL INDEX KIT | DPW | Flowmeter, Blood, Cardiovascular | 2 | DOPPLEX |
9 | 05051968041326 | EZ8XS-USA | EZ8XS-USA | HIGH SENSITIVITY 8MHZ WIDE BEAM | JAF | Monitor, Ultrasonic, Nonfetal | 2 | DOPPLEX |
10 | 05051968041319 | VP10XS-USA | VP10XS-USA | HIGH SENSITIVITY 10MHZ VASCULAR PROBE | JAF | Monitor, Ultrasonic, Nonfetal | 2 | DOPPLEX |
11 | 05051968041302 | VP8XS-USA | VP8XS-USA | HIGH SENSITIVITY 8MHZ VASCULAR PROBE | JAF | Monitor, Ultrasonic, Nonfetal | 2 | DOPPLEX |
12 | 05051968041296 | VP5XS-USA | VP5XS-USA | HIGH SENSITIVITY 5MHZ VASCULAR PROBE | JAF | Monitor, Ultrasonic, Nonfetal | 2 | DOPPLEX |
13 | 05051968041289 | VP4XS-USA | VP4XS-USA | HIGH SENSITIVITY 4MHZ VASCULAR PROBE | JAF | Monitor, Ultrasonic, Nonfetal | 2 | DOPPLEX |
14 | 05051968041272 | OP3XS-USA | OP3XS-USA | HIGH SENSITIVITY 3MHZ OBSTETRIC PROBE | HGL | Transducer, Ultrasonic, Obstetric | 2 | DOPPLEX |
15 | 05051968041265 | OP2XS-USA | OP2XS-USA | HIGH SENSITIVITY 2MHZ OBSTETRIC PROBE | HGL | Transducer, Ultrasonic, Obstetric | 2 | DOPPLEX |
16 | 05051968036544 | DIPP10 | DIPP10 | DIOP8 PROBE PACK | ITX | Transducer, Ultrasonic, Diagnostic | 2 | DOPPLEX |
17 | 05051968032317 | PA8XS | PA8XS | IOP PROBE ADAPTOR, XS | ITX | Transducer, Ultrasonic, Diagnostic | 2 | DOPPLEX |
18 | 05051968032102 | BD4000AXS-2/USA | BD4000AXS-2/USA | ANTEPARTUM FETAL MONITOR BD4000XS-2/USA | HGM | System, Monitoring, Perinatal | 2 | DOPPLEX |
19 | 05051968032089 | BD3002-USA | BD3002-USA | ANTEPARTUM MONITOR USA | HGM | System, Monitoring, Perinatal | 2 | DOPPLEX |
20 | 05051968032058 | D900-DATA/C | D900 DATASCOPE | KNG | Monitor, Ultrasonic, Fetal | 2 | DOPPLEX | |
21 | 05051968031792 | FM830-SL-ENCORE | ENCOR-FM830S-UN | FM830-SL ENCORE COMPLETE SYSTEM | HGM | System, Monitoring, Perinatal | 2 | DOPPLEX |
22 | 05051968031785 | FM820-SL-ENCORE | ENCOR-FM820S-UN | FM820-SL ENCORE COMPLETE SYSTEM | HGM | System, Monitoring, Perinatal | 2 | DOPPLEX |
23 | 05051968031761 | DR4USA-UPGRADE | DR4USA-UPGRADE | DOPPLEX REPORTER DR4 USA UPGRADE | KNG | Monitor, Ultrasonic, Fetal | 2 | DOPPLEX |
24 | 05051968031747 | DR4-USA | DR4-USA | DOPPLEX REPORTER DR4 USA | KNG | Monitor, Ultrasonic, Fetal | 2 | DOPPLEX |
25 | 05051968030542 | VP8/DATA-CE | 0154-01-0005 | DATASCOPE PROBE,8MHZ,CE | KNG | Monitor, Ultrasonic, Fetal | 2 | DOPPLEX |
26 | 05051968030535 | D900/VP8-DATA/C | 0154-01-0001 | DATASCOPE D900 C/W VP8 | KNG | Monitor, Ultrasonic, Fetal | 2 | DOPPLEX |
27 | 05051968030511 | ACC-VAS-027 | ACC-VAS-027 | ADULT CUFF SET | JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 2 | DOPPLEX |
28 | 05051968030504 | ACC-VAS-026 | ACC-VAS-026 | ADULT LEFT ANKLE CUFF | JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 2 | DOPPLEX |
29 | 05051968030498 | ACC-VAS-025 | ACC-VAS-025 | ADULT LEFT ARM CUFF | JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 2 | DOPPLEX |
30 | 05051968030481 | ACC-VAS-024 | ACC-VAS-024 | ADULT RIGHT ANKLE CUFF | JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 2 | DOPPLEX |
31 | 05051968030474 | ACC-VAS-023 | ACC-VAS-023 | ADULT RIGHT ARM CUFF | JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 2 | DOPPLEX |
32 | 05051968030436 | ACC-VAS-019 | ACC-VAS-019 | ROLL SELF ADHSV PAPER PACK(PKD 5) | JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 2 | DOPPLEX |
33 | 05051968030429 | ACC-VAS-017 | ACC-VAS-017 | STANDARD PAPER ROLL (PKD 5) | JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 2 | DOPPLEX |
34 | 05051968030412 | ACC-VAS-016 | ACC-VAS-016 | ABILITY SLEEVES - BOX OF 100 | JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 2 | DOPPLEX |
35 | 05051968030375 | ACC-VAS-011 | ACC-VAS-011 | LARGE ADULT CUFF CUFF SET | JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 2 | DOPPLEX |
36 | 05051968030368 | ACC-VAS-010 | ACC-VAS-010 | LARGE ADULT LEFT ANKLE CUFF | JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 2 | DOPPLEX |
37 | 05051968030351 | ACC-VAS-009 | ACC-VAS-009 | LARGE ADULT LEFT ARM CUFF | JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 2 | DOPPLEX |
38 | 05051968030344 | ACC-VAS-008 | ACC-VAS-008 | LARGE ADULT RIGHT ANKLE CUFF | JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 2 | DOPPLEX |
39 | 05051968030337 | ACC-VAS-007 | ACC-VAS-007 | LARGE ADULT RIGHT ARM CUFF | JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 2 | DOPPLEX |
40 | 05051968030054 | FD3-P | FD3-P-USA | FD3-P USA FETAL DOPPLEX | KNG | Monitor, Ultrasonic, Fetal | 2 | DOPPLEX |
41 | 05051968030047 | D930-P | D930-P-USA | FLEXI DOPPLEX POCKET,USA | KNG | Monitor, Ultrasonic, Fetal | 2 | DOPPLEX |
42 | 05051968030030 | DA100PB | DA100PB/USA | ABILITY/USA PRINTER + BATTERY | JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 2 | DOPPLEX |
43 | 05051968029539 | VP8-HS | VP8-HS | PROBE,8MHZ,HS | KNG | Monitor, Ultrasonic, Fetal | 2 | DOPPLEX |
44 | 05051968029454 | VP5-HS | VP5-HS | PROBE,5MHZ,HS | KNG | Monitor, Ultrasonic, Fetal | 2 | DOPPLEX |
45 | 05051968029416 | VP4-HS | VP4-HS | PROBE,4MHZ,HS | KNG | Monitor, Ultrasonic, Fetal | 2 | DOPPLEX |
46 | 05051968029379 | VP10-HS | VP10-HS | PROBE,10MHZ,HS | KNG | Monitor, Ultrasonic, Fetal | 2 | DOPPLEX |
47 | 05051968028266 | US1 | US1 | BD4000 ULTRASOUND TRANSDUCER | HGM | System, Monitoring, Perinatal | 2 | DOPPLEX |
48 | 05051968025265 | SONICAIDONE | SONICAIDONE | SONICAID ONE | HGL | Transducer, Ultrasonic, Obstetric | 2 | DOPPLEX |
49 | 05051968024459 | SD2-P | SD2-P-USA | SUPER DOPPLEX II POCKET,USA | KNG | Monitor, Ultrasonic, Fetal | 2 | DOPPLEX |
50 | 05051968023070 | PAD-USA | PAD-USA | PAD SCREENING KIT - USA | KNG | Monitor, Ultrasonic, Fetal | 2 | DOPPLEX |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00812311029140 | G8-3035-SH-L-R | 8-Chamber Arm & Shoulder Sleeve - Large, Right | BIO COMPRESSION SYSTEMS, INC | ||
2 | 00812311029133 | G8-3035-SH-L-L | 8-Chamber Arm & Shoulder Sleeve - Large, Left | BIO COMPRESSION SYSTEMS, INC | ||
3 | 00812311029126 | G8-3035-SH-M-R | 8-Chamber Arm & Shoulder Sleeve - Medium, Right | BIO COMPRESSION SYSTEMS, INC | ||
4 | 00812311029119 | G8-3035-SH-M-L | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml# | 8-Chamber Arm & Shoulder Sleeve - Medium, Left | BIO COMPRESSION SYSTEMS, INC | |
5 | 00812311029102 | G8-3035-SH-S-R | 8-Chamber Arm & Shoulder Sleeve - Small, Right | BIO COMPRESSION SYSTEMS, INC | ||
6 | 00812311029096 | G8-3035-SH-S-L | 8-Chamber Arm & Shoulder Sleeve - Small, Left | BIO COMPRESSION SYSTEMS, INC | ||
7 | 00812311029089 | GS-3035-SH-L-R | 4-Chamber Arm & Shoulder Sleeve - Large, Right | BIO COMPRESSION SYSTEMS, INC | ||
8 | 00812311029072 | GS-3035-SH-L-L | 4-Chamber Arm & Shoulder Sleeve - Large, Left | BIO COMPRESSION SYSTEMS, INC | ||
9 | 00812311029065 | GS-3035-SH-M-R | 4-Chamber Arm & Shoulder Sleeve - Medium, Right | BIO COMPRESSION SYSTEMS, INC | ||
10 | 00812311029058 | GS-3035-SH-M-L | 4-Chamber Arm & Shoulder Sleeve - Medium, Left | BIO COMPRESSION SYSTEMS, INC | ||
11 | 00812311029041 | GS-3035-SH-S-R | 4-Chamber Arm & Shoulder Sleeve - Small, Right | BIO COMPRESSION SYSTEMS, INC | ||
12 | 00812311029034 | GS-3035-SH-S-L | 4-Chamber Arm & Shoulder Sleeve - Small, Left | BIO COMPRESSION SYSTEMS, INC | ||
13 | 00812311029027 | SC-3008-DL-BT | BioTAB Sequential Circulator | BIO COMPRESSION SYSTEMS, INC | ||
14 | 00812311029010 | SC-2004-OC-BT | BioTAB Sequential Circulator | BIO COMPRESSION SYSTEMS, INC | ||
15 | 00812311029003 | IC-BAP-DL-BT | BioTAB Bio Arterial Plus | BIO COMPRESSION SYSTEMS, INC | ||
16 | 00812311026484 | SC-4008-DL | Sequential Circulator | BIO COMPRESSION SYSTEMS, INC | ||
17 | 00812311026446 | SC-4004-DL | Sequential Circulator | BIO COMPRESSION SYSTEMS, INC | ||
18 | 00812311026286 | SC-2008-DL | Sequential Circulator | BIO COMPRESSION SYSTEMS, INC | ||
19 | 00812311026248 | SC-2004-DL | Sequential Circulator | BIO COMPRESSION SYSTEMS, INC | ||
20 | 00812311026187 | SC-1008-DL | Sequential Circulator | BIO COMPRESSION SYSTEMS, INC | ||
21 | 00812311026149 | SC-1004-DL | Sequential Circulator | BIO COMPRESSION SYSTEMS, INC | ||
22 | 00812311025982 | GV-3000-8C | Bio Compression Systems 8 Chamber Vest | BIO COMPRESSION SYSTEMS, INC | ||
23 | 00812311024480 | SC-4008-DL-BT | BioTab Sequential Circulator | BIO COMPRESSION SYSTEMS, INC | ||
24 | 00812311024244 | SC-2004-DL-BT | BioTab Sequential Circulator | BIO COMPRESSION SYSTEMS, INC | ||
25 | 00812311023063 | GID-1000-R | VascuEase Replacement Sleeve, Right | BIO COMPRESSION SYSTEMS, INC | ||
26 | 00812311023056 | GID-1000-PR | VascuEase Replacement Sleeves | BIO COMPRESSION SYSTEMS, INC | ||
27 | 00812311023049 | GID-1000-L | VascuEase Replacement Sleeve, Left | BIO COMPRESSION SYSTEMS, INC | ||
28 | 00812311023032 | GV-3010-S-2 | Bio Compression Systems Elite 8 Bio Vest Bilateral Arms | BIO COMPRESSION SYSTEMS, INC | ||
29 | 00812311023025 | GV-3010-L-2 | Bio Compression Systems Elite 8 Bio Vest Bilateral Arms | BIO COMPRESSION SYSTEMS, INC | ||
30 | 00812311023018 | GV-3010-C-2 | Bio Compression Systems Elite 8 Bio Vest Bilateral Arms | BIO COMPRESSION SYSTEMS, INC | ||
31 | 00812311022301 | GS-3045-L-BT | Bio Compression Systems 4 Chamber Leg Sleeve Large | BIO COMPRESSION SYSTEMS, INC | ||
32 | 00812311022295 | GXWA8-3045-BT | Bio Compression Systems 8 Chamber Adjustable Extra Wide Leg | BIO COMPRESSION SYSTEMS, INC | ||
33 | 00812311022288 | GXWA-3045-BT | Bio Compression Systems 4 Chamber Adjustable Extra Wide Leg | BIO COMPRESSION SYSTEMS, INC | ||
34 | 00812311022271 | GXW8-3045-BT | Bio Compression Systems 8 Chamber Extra Wide Leg | BIO COMPRESSION SYSTEMS, INC | ||
35 | 00812311022264 | GXW-3045-BT | Bio Compression Systems 4 Chamber Extra Wide Leg | BIO COMPRESSION SYSTEMS, INC | ||
36 | 00812311022257 | GW8-3045-S-BT | Bio Compression Systems 8 Chamber Wide Leg Small | BIO COMPRESSION SYSTEMS, INC | ||
37 | 00812311022240 | GW8-3045-M-BT | Bio Compression Systems 8 Chamber Wide Leg Medium | BIO COMPRESSION SYSTEMS, INC | ||
38 | 00812311022233 | GW8-3045-L-BT | Bio Compression Systems 4 Chamber Wide Leg Large | BIO COMPRESSION SYSTEMS, INC | ||
39 | 00812311022226 | GW-3045-S-BT | Bio Compression Systems 4 Chamber Wide Leg Small | BIO COMPRESSION SYSTEMS, INC | ||
40 | 00812311022219 | GW-3045-M-BT | Bio Compression Systems 4 Chamber Wide Leg Medium | BIO COMPRESSION SYSTEMS, INC | ||
41 | 00812311022202 | GW-3045-L-BT | Bio Compression Systems 4 Chamber Wide Leg Large | BIO COMPRESSION SYSTEMS, INC | ||
42 | 00812311022196 | GV-3010-M-R-BT | Bio Compression Systems Elite 8 Bio Vest Medium Right | BIO COMPRESSION SYSTEMS, INC | ||
43 | 00812311022189 | GV-3010-M-L-BT | Bio Compression Systems Elite 8 Bio Vest Medium Left | BIO COMPRESSION SYSTEMS, INC | ||
44 | 00812311022172 | GS-3045-S-BT | Bio Compression Systems 4 Chamber Leg Sleeve Small | BIO COMPRESSION SYSTEMS, INC | ||
45 | 00812311022165 | GS-3045-M-BT | Bio Compression Systems 4 Chamber Leg Sleeve Medium | BIO COMPRESSION SYSTEMS, INC | ||
46 | 00812311022158 | SC-3008-IS | Bio Compression Systems Sequential Circulator Model SC-3008-IS | BIO COMPRESSION SYSTEMS, INC | ||
47 | 00812311022141 | SC-3008-DL-230 | Bio Compression Systems Sequential Circulator Model SC-3008-DL-230 | BIO COMPRESSION SYSTEMS, INC | ||
48 | 00812311022127 | SC-3004-DL-230 | Bio Compression Systems Sequential Circulator Model SC-3004-DL-230 | BIO COMPRESSION SYSTEMS, INC | ||
49 | 00812311022110 | SC-2008-IS | Bio Compression Systems Sequential Circulator Model SC-2008-IS | BIO COMPRESSION SYSTEMS, INC | ||
50 | 00812311022103 | SC-2008-IN | Bio Compression Systems Sequential Circulator Model SC-2008-IN | BIO COMPRESSION SYSTEMS, INC |