FDA.reportPublic FDA data

Bio Compression Systems Sequential Circulator Model SC-2004-NZ

Primary DI
00812311022080
Brand
Bio Compression Systems Sequential Circulator Model SC-2004-NZ
Company
Bio Compression Systems, Inc
Model
SC-2004-NZ
Published
2017-11-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00812311022080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812311022080008123110220808123110220800812311022080

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
Premarket exempt
true
Serial number
true

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
00812311020512Multi-FLO DVT Combo Cyro Shoulder SleeveGC1-3035-SH2019-04-09
00812311020543Multi-FLO DVT Combo Cyro Ankle SleeveGC1-3045-A2019-04-09
00812311020567Multi-FLO DVT Combo Cyro Knee SleeveGC1-3045-K2019-04-09
00812311024244BioTab Sequential CirculatorSC-2004-DL-BT2021-08-31
00812311024480BioTab Sequential CirculatorSC-4008-DL-BT2021-08-31
00812311026149Sequential CirculatorSC-1004-DL2021-08-31
00812311026187Sequential CirculatorSC-1008-DL2021-08-31
00812311026248Sequential CirculatorSC-2004-DL2021-08-31
00812311026286Sequential CirculatorSC-2008-DL2021-08-31
00812311026446Sequential CirculatorSC-4004-DL2021-08-31
00812311026484Sequential CirculatorSC-4008-DL2021-08-31
00812311026255BioCryo Sequential CirculatorSC-2004-DL-OTC2022-04-13
00812311020086Bio Compression Systems Carrying Case BlueBCC-1002017-11-21
00812311020871Bio Compression Systems Sequential Circulator Model SC-2004SC-20042017-11-21
00812311021199Bio Compression Systems Bio Arterial Plus Model IC-BAPIC-BAP2017-11-21
00812311021205Bio Compression Systems Bio Arterial Plus Model IC-BAP-230IC-BAP-2302017-11-21
00812311021212Bio Compression Systems Bio Arterial Plus Model IC-BAP-DLIC-BAP-DL2017-11-21
00812311021229Bio Compression Systems Sequential Circulator Model SC-2004-230SC-2004-2302017-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489024500MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-05-18
10193489024531MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-05-18
08809802648494DVT-SERIESDAESUNG MAREF CO.,LTD.JOW2026-02-09
08809802648500DVT-SERIESDAESUNG MAREF CO.,LTD.JOW2026-02-09
08809802646810DVT-2600DAESUNG MAREF CO.,LTD.JOW2025-12-19
08809802646858DVT-4000SDAESUNG MAREF CO.,LTD.JOW2025-12-19
10080196138302MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-10-14
10193489097252MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-10-13
10192253057775CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057782CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057799CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057805CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057812CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057829CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10193489003154MEDLINE RENEWALMEDLINE INDUSTRIES, INC.JOW2025-04-17
10193489003161MEDLINE RENEWALMEDLINE INDUSTRIES, INC.JOW2025-03-21
10080196391974MEDLINE RENEWALMEDLINE INDUSTRIES, INC.JOW2025-03-18
10197344104543MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-03-11
10192253057768CARDINAL HEALTHCardinal Health 200, LLCJOW2025-02-19
10080196385409MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-01-02
10192253016123Kendall SCDCardinal Health 200, LLCJOW2024-12-16
10192253016130Kendall SCDCardinal Health 200, LLCJOW2024-12-16
10192253016185Kendall SCDCardinal Health 200, LLCJOW2024-12-16
10197344098415MEDLINEMEDLINE INDUSTRIES, INC.JOW2024-12-02
10197344006687MEDLINEMEDLINE INDUSTRIES, INC.JOW2024-11-22
10192253057737CARDINAL HEALTHCardinal Health 200, LLCJOW2024-10-02
10197344006694MEDLINEMEDLINE INDUSTRIES, INC.JOW2024-07-08
10197344006700MedlineMEDLINE INDUSTRIES, INC.JOW2024-03-26
10197344006670MedlineMEDLINE INDUSTRIES, INC.JOW2024-03-18
10197106500439CARDINAL HEALTHCardinal Health 200, LLCJOW2023-12-28