FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885380183270
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SV-2XL
Catalog number
SV-2XL
Device description
Surgical Vest Therapeutic Chest Support 2XL
Published
2021-11-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
OTC
true

Product Codes#

Code, Name table
CodeName
HEFBINDER, BREAST

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HEFBinder, BreastGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885380183270PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088538018327010885380183270

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure shirt/pantsA garment in the form of a vest, shirt, pants, leggings, or whole-body suit intended to tightly fit over and apply compression/pressure (i.e., graduated or even-force) to an area of the upper and/or mid/lower body to support skin/subcutaneous healing and scar prevention, to exude excessive interstitial fluid, and/or to help improve proprioception. It is a piece of clothing designed to be worn around the hips and/or shoulders, and is neither a strip/roll binder, limb sleeve, glove, nor sock. It is typically made of cotton or synthetic elastic material (e.g., Lycra); it does not include antimicrobial features. Absorbent pads may be used underneath the device. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956232792CARDINAL HEALTHSOP3IOLUTASOP3IOLUTA2026-07-16
10198956260016CARDINAL HEALTHSNE23SPMABSNE23SPMAB2026-07-16
10198956319929CARDINAL HEALTHSAN55TPKFCSAN55TPKFC2026-07-16
10198956326484CARDINAL HEALTH03-1708O03-1708O2026-07-16
10198956334342CARDINAL HEALTHPO21FKEGBPO21FKEGB2026-07-16
10198956335523CARDINAL HEALTHSAN19CCKHOSAN19CCKHO2026-07-16
10198956344020CARDINAL HEALTHSCV73OPBHCSCV73OPBHC2026-07-16
10198956359611CARDINAL HEALTHPO24ARSMCPO24ARSMC2026-07-16
10198956360112CARDINAL HEALTHSMA55DPKCSSMA55DPKCS2026-07-16
10198956364837CARDINAL HEALTHPO54KTGCCPO54KTGCC2026-07-16
10198956368002CARDINAL HEALTHSOPHDUPUBDSOPHDUPUBD2026-07-16
10198956382381CARDINAL HEALTHSCV5DPPUMDSCV5DPPUMD2026-07-16
10198956382930CARDINAL HEALTHSEY48CPOELSEY48CPOEL2026-07-16
10198956388178CARDINAL HEALTHSENHDTAHGDSENHDTAHGD2026-07-16
10198956390546CARDINAL HEALTHSEYHDEYSPBSEYHDEYSPB2026-07-16
10198956392755CARDINAL HEALTHSOPOCPPAEBSOPOCPPAEB2026-07-16
10198956395886CARDINAL HEALTHSAN53EPVSFSAN53EPVSF2026-07-16
10198956400856CARDINAL HEALTH08-0077C08-0077C2026-07-16
10198956408401CARDINAL HEALTHSOPVXEXBMESOPVXEXBME2026-07-16
10198956418431CARDINAL HEALTHSAN69BPKIBSAN69BPKIB2026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817612021053Dale Post Surgical Compression BraDale Medical Products, Inc.HEF2025-03-31
00817612021060Dale Post Surgical Compression BraDale Medical Products, Inc.HEF2025-03-31
00817612021077Dale Post Surgical Compression BraDale Medical Products, Inc.HEF2025-03-31
00817612021084Dale Post Surgical Compression BraDale Medical Products, Inc.HEF2025-03-31
00817612021091Dale Post Surgical Compression BraDale Medical Products, Inc.HEF2025-03-31
00817612020964Dale Post Surgical BraDale Medical Products, Inc.HEF2024-04-25
00653160038316CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHEF2022-01-01
50653160038311CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHEF2022-01-01
10885380183201CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183218CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183225CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183232CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183249CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183256CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183263CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183287CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183294CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183317CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183324CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183331CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
00082161080053NuRooBROWNMED, INC.HEF2020-08-13
00082161080060NuRooBROWNMED, INC.HEF2020-08-13
00082161080077NuRooBROWNMED, INC.HEF2020-08-13
00082161080084NuRooBROWNMED, INC.HEF2020-08-13
00849174080001NuRooBROWNMED, INC.HEF2020-08-13
00849174080308NuRooBROWNMED, INC.HEF2020-08-13
00817612020452Dale Post Surgical BraDale Medical Products, Inc.HEF2019-06-24
00817612020469Dale Post Surgical BraDale Medical Products, Inc.HEF2019-06-24
00817612020476Dale Post Surgical BraDale Medical Products, Inc.HEF2019-06-24
00817612020483Dale Post Surgical BraDale Medical Products, Inc.HEF2019-06-24