FDA.reportPublic FDA data

Bio Compression Systems Sequential Circulator Model SC-2004-IS

Primary DI
00812311022073
Brand
Bio Compression Systems Sequential Circulator Model SC-2004-IS
Company
Bio Compression Systems, Inc
Model
SC-2004-IS
Published
2017-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOWSLEEVE, LIMB, COMPRESSIBLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOWSleeve, Limb, CompressibleCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812311022073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812311022073008123110220738123110220730812311022073

GMDN Terms#

Term, Definition table
TermDefinition
Sequential venous compression system pumpAn electrically-powered device used for the noninvasive treatment and prevention of venous disorders/sequelae. As part of a compression system, the pump provides the connected stocking/sleeve/suit with the necessary pressure to promote venous blood flow. This is achieved through the sequential inflation and deflation of the multi-chambered stocking/sleeve/suit applied to the extremities. It typically consists of a compressor with advanced control/timing mechanism, pressure limiting device, tubing, and connectors. The resulting increased venous blood flow may help to treat/prevent oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE) in non-ambulatory patients or patients at risk.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(201)340-6422barbaraw@biocompression.com

Regulatory Flags#

DUNS number
101393924
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812311022363BIOARTERIAL+IC-BAP-DX-BT2026-03-09
00812311022479Bio Arterial DeluxeIC-BAP-DX2026-02-13
00812311026255BioCryo Sequential CirculatorSC-2004-DL-OTC2022-04-13
008123110200628-Chamber Arm & Shoulder Sleeve - Medium, LeftG8-3035-SH-M-L-BT2021-09-01
008123110202088-Chamber Arm & Shoulder Sleeve - Medium, RightG8-3035-SH-M-R-BT2021-09-01
00812311021700Bio Compression Systems 8 Chamber Leg Sleeve - LargeG8-3045-L-BT2021-09-01
00812311021717Bio Compression Systems 8 Chamber Leg Sleeve - MediumG8-3045-M-BT2021-09-01
00812311021724Bio Compression Systems 8 Chamber Leg Sleeve - SmallG8-3045-S-BT2021-09-01
00812311021731Bio Compression Systems 4 Chamber Leg Sleeve Large NarrowGN-3045-L-BT2021-09-01
00812311021816Bio Compression Systems 4 Chamber Leg Sleeve Medium NarrowGN-3045-M-BT2021-09-01
00812311021946Bio Compression Systems 4 Chamber Leg Sleeve Small NarrowGN-3045-S-BT2021-09-01
00812311021953Bio Compression Systems 8 Chamber Leg Sleeve Large NarrowGN8-3045-L-BT2021-09-01
00812311021960Bio Compression Systems 8 Chamber Leg Sleeve Medium NarrowGN8-3045-M-BT2021-09-01
00812311021977Bio Compression Systems 4 Chamber Arm Sleeve MediumGS-3035-M-BT2021-09-01
008123110219844-Chamber Arm & Shoulder Sleeve - Medium, LeftGS-3035-SH-M-L-BT2021-09-01
008123110219914-Chamber Arm & Shoulder Sleeve - Medium, RightGS-3035-SH-M-R-BT2021-09-01
00812311022004Bio Compression Systems 4 Chamber Leg Sleeve HalfGS-3045-H-BT2021-09-01
00812311022165Bio Compression Systems 4 Chamber Leg Sleeve MediumGS-3045-M-BT2021-09-01
00812311022172Bio Compression Systems 4 Chamber Leg Sleeve SmallGS-3045-S-BT2021-09-01
00812311022189Bio Compression Systems Elite 8 Bio Vest Medium LeftGV-3010-M-L-BT2021-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719893351026WellellWellell Inc.JOW2026-03-17
00812311022363BIOARTERIAL+Bio Compression Systems, IncJOW2026-03-09
00850033615272ThermoTek WRAP, DVT, CALF SET, PUSH, SPUTHERMOTEK, INC.JOW2026-02-21
00850033615494ThermoTek WRAP,DVT,CA,SET,PUSH,SPU, QTY 10, CTNTHERMOTEK, INC.JOW2026-02-21
00812311022479Bio Arterial DeluxeBio Compression Systems, IncJOW2026-02-13
00850001096386Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096393Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096409Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096416Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096423Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096430Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096447Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096461Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096478Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096485Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096492Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096508Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096522Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096539Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096546Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096553Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
10885380185120KendallCardinal Health 200, LLCJOW2026-02-10
18809802648491DVT-SERIESDAESUNG MAREF CO.,LTD.JOW2026-02-09
18809802648507DVT-SERIESDAESUNG MAREF CO.,LTD.JOW2026-02-09
10816317024427Kendall DVT SleeveRENU MEDICAL, INCJOW2026-01-27
10816317024434Kendall DVT SleeveRENU MEDICAL, INCJOW2026-01-27
10816317024441Kendall DVT SleeveRENU MEDICAL, INCJOW2026-01-27
00850031012615AIROSAIROS MEDICAL INCJOW2026-01-23
10850031012629AIROSAIROS MEDICAL INCJOW2026-01-23
10850031012636AIROSAIROS MEDICAL INCJOW2026-01-23