FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885380183317
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SV-LRG
Catalog number
SV-LRG
Device description
Surgical Vest Therapeutic Chest Support Large
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
10885380183317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088538018331710885380183317

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
10192253015553T.E.D.399539952026-06-19
20192253016748Kendall22853228532021-05-19
20192253016755Kendall2285522855-2021-02-23
20192253017455Kendall31469219314692192021-05-05
20192253017547Medi-Trace Cadence22550A22550A-2021-07-28
20192253017554Medi-Trace Cadence22550P22550P-2021-08-19
20192253017578Medi-Trace Cadence22550PC22550PC2021-07-29
20192253017585Medi-Trace Cadence22550R22550R-2021-07-29
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
20192253017622Medi-Trace Cadence22770P22770P2021-08-19
20192253017639Medi-Trace Cadence22770PC22770PC2021-07-29
20192253017721Kendall31319281313192812021-05-05
20192253018889Medi-Trace Cadence22770R22770R-2021-07-29
20192253020240Kerlix332433242020-09-22
50192253020197Kerlix189218922020-08-12
50192253020357Kerlix673567352020-08-12
50192253020364Kerlix788278822020-08-12
50192253050422Devon31142931311429312023-07-10
20192253017592Medi-Trace Cadence22660PC22660PC2021-07-29
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04

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
10885380183270CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183287CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183294CARDINAL 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