FDA.reportPublic FDA data

McKesson

Primary DI
00612479120068
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
53831100
Device description
Disposable Procedure Gowns White Full BACK Elastic CUFFS FLUID RESISTANT NECK & WAIST TIES Universal
Published
2020-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
00612479120068PrimaryGS10
00612479236431Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479120068006124791200686124791200680612479120068
00612479236431006124792364316124792364310612479236431

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/examination garment kitA collection of apparel items intended to be worn by healthcare staff during a patient examination or surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. It consists of one or more of the following types of items (which may be worn over a scrub suit): gowns, aprons, shoe covers, sleeve covers, caps, drapes, gloves and surgical face masks. It may in addition include items intended to be worn by the patient to prevent cross-contamination, and hand sanitizing products (e.g., alcohol gel). This is a single-use device.

Regulatory Flags#

DUNS number
023904428
Device count
50
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10612479235592McKesson16-18502020-06-10
10612479235608McKesson16-18522020-06-10
10612479258317McKesson16-18602020-06-25
10612479258348McKesson16-18622020-06-25
20612479203710McKesson326302020-07-21
10612479169064McKesson101-87032016-12-09
10612479169125McKesson101-87102016-12-09
10612479284002McKesson16-6219-B2026-08-03
10612479284026McKesson16-6218-B2026-08-03
10612479284040McKesson16-6220-B2026-08-03
10612479284064McKesson16-6221-B2026-08-03
10612479284101McKesson16-6379-B2026-08-03
10612479284125McKesson16-6216-B2026-08-03
00612479151291McKesson16-DEN-12026-07-09
00612479274648McKesson48392025-01-17
20612479285723McKessonGCCOV-502a-MB2026-06-18
20612479285747McKessonCCOVAg-PNMB2026-06-18
00612479271050McKesson16-L2NWT6Y-XL2024-04-17
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840118620444ENDURE INDUSTRIESENDURE INDUSTRIESFME2026-08-03
00840118620468ENDURE INDUSTRIESENDURE INDUSTRIESFME2026-08-03
00840118620482ENDURE INDUSTRIESENDURE INDUSTRIESFME2026-08-03
00842942015441PRIMEDpriMED Medical Products IncFME2026-02-10
16975803530881GSOGroup Supply Organization Medical Technology(Shanghai) LtdFME2025-11-30
00842942017520PRIMED / CaracalpriMED Medical Products IncFME2025-11-26
00842942017537PRIMED / CaracalpriMED Medical Products IncFME2025-11-26
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00842942009365PRIMEDpriMED Medical Products IncFME2025-07-21
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00842942009556PRIMEDpriMED Medical Products IncFME2025-07-21
00842942009563PRIMEDpriMED Medical Products IncFME2025-07-21
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00842942014475PRIMEDpriMED Medical Products IncFME2025-07-21
00842942014482PRIMEDpriMED Medical Products IncFME2025-07-21
00842942016080PRIMEDpriMED Medical Products IncFME2025-07-21
05391534524410PRIMEDpriMED Medical Products IncFME2025-07-21
05391534524441PRIMEDpriMED Medical Products IncFME2025-07-15
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