No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00812311029140 | G8-3035-SH-L-R | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | 8-Chamber Arm & Shoulder Sleeve - Large, Right | ||
2 | 00812311029089 | GS-3035-SH-L-R | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | 4-Chamber Arm & Shoulder Sleeve - Large, Right | ||
3 | 00812311022172 | GS-3045-S-BT | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 4 Chamber Leg Sleeve Small | ||
4 | 00812311022042 | IC-1545-DLI | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems Multi-Flo DVT Model IC-1545-DLI | ||
5 | 00812311021908 | GS-3045-L/B | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 4 Chamber Leg Sleeve Large Black | ||
6 | 00812311021861 | GC-3045-XL/B | IRP,ILO | Massager, Powered Inflatable Tube,Pack, Hot Or Cold, Water Circulating | 2 | Bio Compression Systems 4 Chamber Cryo Leg Extra Large - Black | ||
7 | 00812311021724 | G8-3045-S-BT | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 8 Chamber Leg Sleeve - Small | ||
8 | 00812311021618 | GC-3045-KC | IRP,ILO | Massager, Powered Inflatable Tube,Pack, Hot Or Cold, Water Circulating | 2 | Bio Compression Systems BioCryo Knee | ||
9 | 00812311021601 | GC-3045-A | IRP,ILO | Massager, Powered Inflatable Tube,Pack, Hot Or Cold, Water Circulating | 2 | Bio Compression Systems BioCryo Ankle | ||
10 | 00812311021564 | SC-3004-DL | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems Sequential Circulator Model SC-3004-DL | ||
11 | 00812311021281 | SC-3004 | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems Sequential Circulator Model SC-3004 | ||
12 | 00812311021151 | IC-1545-F | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems Multi-Flo DVT Model IC-1545-F | ||
13 | 00812311020888 | GS-3045-S | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 4 Chamber Leg Sleeve Small | ||
14 | 00812311020819 | GS-3035-SH/L | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 4 Chamber Arm and Shoulder Sleeve Large | ||
15 | 00812311020741 | GN-3045-S/B | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 4 Chamber Leg Sleeve Small Narrow - Black | ||
16 | 00812311020406 | GBA-3045-L-L | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems Bio Abdominal Left Leg - Large | ||
17 | 00812311020390 | GA-3045-S | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 4 Chamber Adjustable Leg - Small | ||
18 | 00812311020321 | G8-3045-S | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 8 Chamber Leg Sleeve - Small | ||
19 | 00812311020291 | G8-3035-SH/S | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 8 Chamber Arm & Shoulder Sleeve - Small | ||
20 | 00812311020284 | G8-3035-SH/M | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 8 Chamber Arm & Shoulder Sleeve - Medium | ||
21 | 00812311020123 | CG-3035-C | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems Custom 4 Chamber Arm Sleeve | ||
22 | 00812311020086 | BCC-100 | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems Carrying Case Blue | ||
23 | 00812311020024 | A8-3045-M | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 8 Chamber Leg Sleeve - Medium Adjustable | ||
24 | 00812311023667 | CI-3035-B | IRP | Massager, Powered Inflatable Tube | 2 | Bio Compression Systems Cryo Insert Back | ||
25 | 00812311023063 | GID-1000-R | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | VascuEase Replacement Sleeve, Right | ||
26 | 00812311022080 | SC-2004-NZ | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems Sequential Circulator Model SC-2004-NZ | ||
27 | 00812311021885 | GID-3045-T | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems DVT Calf/Thigh Sleeve Digital Pair | ||
28 | 00812311021762 | GC-3035-EC/B | IRP,ILO | Massager, Powered Inflatable Tube,Pack, Hot Or Cold, Water Circulating | 2 | Bio Compression Systems 4 Chamber Cryo Elbow Cylinder - Black | ||
29 | 00812311021700 | G8-3045-L-BT | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 8 Chamber Leg Sleeve - Large | ||
30 | 00812311021540 | SC-2004-OC | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems Sequential Circulator Model SC-2004-OC | ||
31 | 00812311021441 | GV-3010-L-R | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems Elite 8 Bio Vest Large Right | ||
32 | 00812311021229 | SC-2004-230 | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems Sequential Circulator Model SC-2004-230 | ||
33 | 00812311021182 | IC-1545-PSP | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems Multi-Flo DVT Model IC-1545-PSP | ||
34 | 00812311021175 | IC-1545-P | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems Multi-Flo DVT Model IC-1545-P | ||
35 | 00812311021083 | GWA8-3045-M | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 8 Chamber Adjustable Wide Leg Medium | ||
36 | 00812311020727 | GN-3045-M/B | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 4 Chamber Leg Sleeve Medium Narrow - Black | ||
37 | 00812311020628 | GC-3045-L | IRP,ILO | Massager, Powered Inflatable Tube,Pack, Hot Or Cold, Water Circulating | 2 | Bio Compression Systems 4 Chamber Cryo Leg Large | ||
38 | 00812311020543 | GC1-3045-A | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Multi-FLO DVT Combo Cyro Ankle Sleeve | ||
39 | 00812311020383 | GA-3045-M | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 4 Chamber Adjustable Leg - Medium | ||
40 | 00812311020338 | GA-3035-L | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 4 Chamber Adjustable Arm - Large | ||
41 | 00812311020307 | G8-3045-L | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 8 Chamber Leg Sleeve - Large | ||
42 | 00812311020260 | G8-3035-S | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems 8 Chamber Arm Sleeve - Small | ||
43 | 00812311020239 | CP-S | IRP | Massager, Powered Inflatable Tube | 2 | Bio Compression Systems Bio Cryo Gel Insert - Small | ||
44 | 00812311020048 | APG-3035-FA | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | Bio Compression Systems Arterial Full Arm Sleeve | ||
45 | 00812311022011 | IC-1200-WH | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | VascuEase | ||
46 | 00812311029119 | G8-3035-SH-M-L | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml# | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | 8-Chamber Arm & Shoulder Sleeve - Medium, Left | |
47 | 00812311029096 | G8-3035-SH-S-L | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | 8-Chamber Arm & Shoulder Sleeve - Small, Left | ||
48 | 00812311029027 | SC-3008-DL-BT | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | BioTAB Sequential Circulator | ||
49 | 00812311029010 | SC-2004-OC-BT | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | BioTAB Sequential Circulator | ||
50 | 00812311027610 | CI-3035-E | IRP | Massager, Powered Inflatable Tube | 2 | Bio Compression Systems Cryo Insert Elbow |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00852597007395 | PB01 Right K | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
2 | 00852597007388 | PB01 Left K | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
3 | 00852597007371 | PB01 Right J | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
4 | 00852597007364 | PB01 Left J | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
5 | 00852597007357 | PB01 Right W I | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
6 | 00852597007340 | PB01 Left W I | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
7 | 00852597007333 | PB01 Right W H | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
8 | 00852597007326 | PB01 Left W H | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
9 | 00852597007319 | PB01 Right W G | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
10 | 00852597007302 | PB01 Left W G | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
11 | 00852597007296 | PB01 Right W F | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
12 | 00852597007289 | PB01 Left W F | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
13 | 00852597007272 | PB01 Right W E | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
14 | 00852597007265 | PB01 Left W E | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
15 | 00852597007258 | PB01 Right W D | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
16 | 00852597007241 | PB01 Left W D | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
17 | 00852597007234 | PB01 Right W C | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
18 | 00852597007227 | PB01 Left W C | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
19 | 00852597007210 | PB01 Right W B | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
20 | 00852597007203 | PB01 Left W B | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
21 | 00852597007197 | PB01 Right W A | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
22 | 00852597007180 | PB01 Left W A | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
23 | 00852597007173 | PB01 Right I | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
24 | 00852597007166 | PB01 Left I | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
25 | 00852597007159 | PB01 Right H | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
26 | 00852597007142 | PB01 Left H | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
27 | 00852597007135 | PB01 Right G | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
28 | 00852597007128 | PB01 Left G | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
29 | 00852597007111 | PB01 Right F | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
30 | 00852597007104 | PB01 Left F | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
31 | 00852597007098 | PB01 Right E | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
32 | 00852597007081 | PB01 Left E | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
33 | 00852597007074 | PB01 Right D | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
34 | 00852597007067 | PB01 Left D | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
35 | 00852597007050 | PB01 Right C | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
36 | 00852597007043 | PB01 Left C | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
37 | 00852597007036 | PB01 Right B | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
38 | 00852597007029 | PB01 Left B | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
39 | 00852597007012 | PB01 Right A | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
40 | 00852597007005 | PB01 Left A | PulseFlow DF™ | PULSE FLOW TECHNOLOGIES | ||
41 | 00850998008898 | ManaFlow 52 | MFLOW52 | The ManaFlow is a four-chamber tubeless pneumatic compression device used to tre The ManaFlow is a four-chamber tubeless pneumatic compression device used to treat lymphedema or aid in the prevention of DVT.Portable and lightweightManaFlow 52 allows the user or clinician to calibrate the pressure in each of the four chambersPatient compliance monitor and pressure monitor | ManaMed | MANAMED INC |
42 | 00850998008867 | Lasso | M-32 | Barrier sleeves (10 pairs/box) | ManaMed | MANAMED INC |
43 | 00850998008850 | Theriot | M-31 | Reusable universal compression calf garment | ManaMed | MANAMED INC |
44 | 00850998008287 | MFLOW52 | MFLOW2 | Compressible Limb Sleeve Device, Pneumatic compressor, segmental home model with Compressible Limb Sleeve Device, Pneumatic compressor, segmental home model without calibrated gradient pressure | ManaFlow52 | MANAMED INC |
45 | 00850998008270 | MFLOW51 | MFLOW51 | Compressible Limb Sleeve Device, Pneumatic compressor, segmental home model with Compressible Limb Sleeve Device, Pneumatic compressor, segmental home model without calibrated gradient pressure | ManaFlow51 | MANAMED INC |
46 | 00850998008027 | C800 | C800 | The Circul8 is intended to be an easy to use sequential compression system, pres The Circul8 is intended to be an easy to use sequential compression system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (stimulating muscle contractions). This device can be used to: Aid in the prevention of DVT Enhance blood circulation Diminish post-operative pain and swelling Reduce wound healing time Aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs. | Circul8 | MANAMED INC |
47 | 00850998008010 | PFE0001 | PFE0001 | The PlasmaFlow ELITE is intended to be an easy to use sequential compression sys The PlasmaFlow ELITE is intended to be an easy to use sequential compression system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (stimulating muscle contractions). This device can be used to: Aid in the prevention of DVT Enhance blood circulation Diminish post-operative pain and swelling Reduce wound healing time Aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs. | PlasmaFlow Elite | MANAMED INC |
48 | 00850998008003 | PF0001 | PF0001 | The PlasmaFlow is intended to be an easy to use sequential compression system, p The PlasmaFlow is intended to be an easy to use sequential compression system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (stimulating muscle contractions). This device can be used to: Aid in the prevention of DVT Enhance blood circulation Diminish post-operative pain and swelling Reduce wound healing time Aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs. | PlasmaFlow | MANAMED INC |
49 | 00850012532651 | F-0085-01 | F-0085-01 | CONTROLLER, DAYSPRING, LITE | DAYSPRING | KOYA MEDICAL, INC. |
50 | 00850012532644 | F-0050-01 | F-0050-01 | LOWER LEG GARMENT, DAYSPRING | DAYSPRING | KOYA MEDICAL, INC. |