FDA.reportPublic FDA data

MARK3

Primary DI
D7963630CBS1
Brand
MARK3
Company
CARGUS INTERNATIONAL, INC
Model
3630CBS
Catalog number
3630CBS
Device description
Protect Plus Jackets Hip Length Ceil Blue Small 10/Pk. - MARK3
Published
2022-01-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMEGown, Examination

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMEGown, ExaminationGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D7963630CBS1PrimaryHIBCC0
D7963630CBS2Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Professional examination gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers, sometimes over scrub suits, while examining patients. It can be fluid resistant or impervious to fluid. An examination gown is used during patient examination procedures to protect both the patient and staff from the transfer of contaminants such as microorganisms or body fluids. This is a single-use garment.

Contacts#

Phone, Email table
PhoneEmail
1-888-732-2913ggabai@Cargus.com

Regulatory Flags#

DUNS number
096191093
Device count
10
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850014374983MARK3®597259722026-02-05
00850014374990MARK3®597459742026-02-05
00850014374648MARK3863-014C863-014C2025-10-16
00850014374655MARK3837-018XC837-018XC2025-10-16
D79690931MARK3909390932022-03-25
D79690901MARK390902017-04-14
D79690911MARK390912017-04-14
D79690921MARK390922017-04-14
D79641251MARK3412541252022-05-27
D79641261MARK3412641262022-05-27
D79653701MARK3537053702022-05-19
D79690031MARK390032025-03-06
D7969003MARK390032025-03-06
D79690011MARK390012025-02-28
D7969001MARK390012025-02-28
D7966125CS1MARK36125CS2021-04-22
D7966127CS1MARK36127CS2021-04-22
D7966129CS1MARK36129CS2021-04-23
D79661270MARK361272021-04-23
D79661290MARK361292021-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16975803530881GSOGroup Supply Organization Medical Technology(Shanghai) LtdFME2025-11-30
10097604573327Tronex International, Inc.TRONEX INTERNATIONAL, INC.FME2024-12-30
10850053289511SURGYCOSurgyco LLCFME2024-08-09
10850053289559SURGYCOSurgyco LLCFME2024-08-09
10850053289566SURGYCOSurgyco LLCFME2024-08-09
10850053289573SURGYCOSurgyco LLCFME2024-08-09
10850053289740SURGYCOSurgyco LLCFME2024-08-09
10850053289757SURGYCOSurgyco LLCFME2024-08-09
10810141931388VIVIT SupplyVivit Supply LLCFME2024-01-19
10810141931395VIVIT SupplyVivit Supply LLCFME2024-01-19
10850045738065UNCThe University of North Carolina Health SystemFME2023-10-31
10810141930473VIVIT SupplyVivit Supply LLCFME2023-09-15
10810141930480VIVIT SupplyVivit Supply LLCFME2023-09-15
10810141930497VIVIT SupplyVivit Supply LLCFME2023-09-15
10810141930503VIVIT SupplyVivit Supply LLCFME2023-09-15
10810141930176VIVIT SupplyVivit Supply LLCFME2023-09-10
10810141930183VIVIT SupplyVivit Supply LLCFME2023-09-10
10810141930190VIVIT SupplyVivit Supply LLCFME2023-09-10
10810141930206VIVIT SupplyVivit Supply LLCFME2023-09-10
10810141930213VIVIT SupplyVivit Supply LLCFME2023-09-10
10810141930220VIVIT SupplyVivit Supply LLCFME2023-09-10
10810141930237VIVIT SupplyVivit Supply LLCFME2023-09-10
10810141930244VIVIT SupplyVivit Supply LLCFME2023-09-10
10850044799890SURGYCOSurgyco LLCFME2023-06-30
10850044799906SURGYCOSurgyco LLCFME2023-06-30
10850044799913SURGYCOSurgyco LLCFME2023-06-30
10850044799937SURGYCOSurgyco LLCFME2023-06-30
10850044799944SURGYCOSurgyco LLCFME2023-06-30
20612899005482EncompassEncompass Group, L.L.C.FME2023-06-21
20612899005499EncompassEncompass Group, L.L.C.FME2023-06-21