FDA.report

CARDINAL HEALTH

Primary DI
10885380183287
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SV-3XL
Catalog number
SV-3XL
Device description
Surgical Vest Therapeutic Chest Support 3XL
Published
2021-11-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HEFBINDER, BREAST

Product Code Classifications

CodeDeviceSpecialtyClass
HEFBinder, BreastGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10885380183287PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088538018328710885380183287

GMDN Terms

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

Regulatory Flags

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

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Primary DIBrandCompanyProduct codePublished
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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
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
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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
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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
H84107021Dale Post Surgical BraDALE MEDICAL PRODUCTS, INC.HEF2018-08-27
H84107031Dale Post Surgical BraDALE MEDICAL PRODUCTS, INC.HEF2018-08-27
H84107041Dale Post Surgical BraDALE MEDICAL PRODUCTS, INC.HEF2018-08-27
H84107051Dale Post Surgical BraDALE MEDICAL PRODUCTS, INC.HEF2018-08-27
H84107061Dale Post Surgical BraDALE MEDICAL PRODUCTS, INC.HEF2018-08-27