FDA.reportPublic FDA data

Bio Compression Systems BioCryo Elbow

Primary DI
00812311021571
Brand
Bio Compression Systems BioCryo Elbow
Company
Bio Compression Systems, Inc
Model
GC-3035-EC
Published
2017-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILOPack, Hot Or Cold, Water Circulating
IRPMassager, Powered Inflatable Tube
JOWSLEEVE, LIMB, COMPRESSIBLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILOPack, Hot Or Cold, Water CirculatingPhysical Medicine2
IRPMassager, Powered Inflatable TubePhysical Medicine2
JOWSleeve, Limb, CompressibleCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961425000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961425000BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELSBio Compression Systems, Inc.1996-10-28ILO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812311021571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812311021571008123110215718123110215710812311021571

GMDN Terms#

Term, Definition table
TermDefinition
Multi-chamber venous compression system garment, reusableAn inflatable device in the form of a stocking, sleeve, or suit that is applied to the limbs externally to promote venous blood flow. As part of a compression system, the device applies pressure to the extremities through the sequential inflation of several chambers. 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. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
101393924
Device count
1
Lot or batch
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
08809040526691AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
08809040526707AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
08809040526714AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
08809040526721AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
04719893351026WellellWellell Inc.JOW2026-03-17
08809040526776Air Relax Classic Model AR-1.0 ControlUnit OnlyMaxstar Industrial Co.,Ltd.IRP2025-10-01
08809040526783Air Relax Classic Model AR-1.0 Leg Recovery System-Size 2Maxstar Industrial Co.,Ltd.IRP2025-10-01
08809040526790Air Relax Classic Model AR-1.0 Leg Recovery System-Size 3Maxstar Industrial Co.,Ltd.IRP2025-10-01
08809040526806Air Relax Classic Model AR-1.0 Leg Recovery System-Size 4Maxstar Industrial Co.,Ltd.IRP2025-10-01
10885380184895CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25
10885380184901CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25
10885380184918CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25
10885380184925CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25
08809315676984LF900DAESUNG MAREF CO.,LTD.IRP2023-03-08
08809277423466WONJINWONJIN MULSAN CO.LTDIRP2022-01-11
08809315672252SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315672269SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315672276SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315672283SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315672290SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315672306SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315672375SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315672382SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315672399SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315672405SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315672412SP-2000DAESUNG MAREF CO.,LTD.IRP2021-12-17
08809315671866SP-1000DAESUNG MAREF CO.,LTD.IRP2021-12-15
08809315671873SP-1000DAESUNG MAREF CO.,LTD.IRP2021-12-15
08809315671880SP-1000DAESUNG MAREF CO.,LTD.IRP2021-12-15
08809315671897SP-1000DAESUNG MAREF CO.,LTD.IRP2021-12-15