FDA.reportPublic FDA data

Sequential Circulator

Primary DI
00812311022448
Brand
Sequential Circulator
Company
Bio Compression Systems, Inc
Model
SC-4104-DL
Published
2026-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
JOWSLEEVE, LIMB, COMPRESSIBLE

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K261807000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K261807000Sequential Circulator (SC-4004-DL, SC-4008-DL)Bio Compression Systems, Inc.2026-09-11JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812311022448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812311022448008123110224488123110224480812311022448

GMDN Terms#

Term, Definition table
TermDefinition
Sequential venous compression system inflatorAn electrically-powered device intended to be 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 applied to the extremities with the necessary pressure to promote venous blood flow through its sequential inflation and deflation. Also referred to as a pump, 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.

Regulatory Flags#

DUNS number
101393924
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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
00812311022486Sequential CirculatorSC-4108-DL2026-09-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812311022486Sequential CirculatorBio Compression Systems, IncJOW2026-09-29
00190446979128AIRCASTDJO, LLCJOW2026-08-03
50885380194564KendallCardinal Health 200, LLCJOW2026-07-31
50885380194571KendallCardinal Health 200, LLCJOW2026-07-31
50885380194588KendallCardinal Health 200, LLCJOW2026-07-31
50885380194601KendallCardinal Health 200, LLCJOW2026-07-31
50885380194618KendallCardinal Health 200, LLCJOW2026-07-31
50885380194625KendallCardinal Health 200, LLCJOW2026-07-31
50885380194632KendallCardinal Health 200, LLCJOW2026-07-31
50885380194649KendallCardinal Health 200, LLCJOW2026-07-31
50885380194656KendallCardinal Health 200, LLCJOW2026-07-31
50885380194663KendallCardinal Health 200, LLCJOW2026-07-31
50885380194670KendallCardinal Health 200, LLCJOW2026-07-31
50885380194694KendallCardinal Health 200, LLCJOW2026-07-31
10888277348226MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-29
10193489024517MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-22
10888277348141MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-22
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