FDA.reportPublic FDA data

PrimaPro

Primary DI
00850022371592
Brand
PrimaPro
Company
PRIMARY PRODUCTS COMPANY
Model
3XL-PE-GOWN
Catalog number
3XL-PE-GOWN
Device description
PrimaPro GentleWare Polyethylene Isolation Gown with Thumbholes 3XL, 15 Gowns/Box, 5 Box/Case, 75 Gowns/Case, Single Use
Published
2021-08-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10850022371599PackageGS15In Commercial Distribution
00850022371592PrimaryGS10
20850022371596Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085002237159910850022371599
00850022371592008500223715928500223715920850022371592
2085002237159620850022371596

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.

Regulatory Flags#

DUNS number
089569581
Device count
15
Premarket exempt
true
Lot or batch
true
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850022371424PrimaPro611-452020-09-09
00850022371431PrimaPro612-452020-09-09
00850022371448PrimaPro613-452020-09-09
00850022371455PrimaPro614-452020-09-09
00850022371523PrimaPro421-452020-12-30
00850022371530PrimaPro422-452020-12-30
00850022371547PrimaPro423-452020-12-30
00850022371554PrimaPro424-452020-12-30
00850022371561PrimaPro610-45420-45N2026-04-28
00850022371578PrimaPro525-452025-02-12
00850022371585PrimaPro520-452025-02-12
00850022371622PrimaPro275-452025-02-12
10850022371575PrimaPro525-452025-02-12
10850022371582PrimaPro520-452025-02-12
10850022371629PrimaPro275-452025-02-12
00850022371301PrimaPro311-452020-09-09
00850022371318PrimaPro312-452020-09-09
00850022371325PrimaPro313-452020-09-09
00850022371332PrimaPro314-452020-09-09
00850022371479PrimaProW182028EL-BX2020-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00842942007828PRIMEDpriMED Medical Products IncFME2025-07-21
00842942008207PRIMEDpriMED Medical Products IncFME2025-07-21
00842942009341PRIMEDpriMED Medical Products IncFME2025-07-21
00842942009358PRIMEDpriMED Medical Products IncFME2025-07-21
00842942009365PRIMEDpriMED Medical Products IncFME2025-07-21
00842942009372PRIMEDpriMED Medical Products IncFME2025-07-21
00842942009556PRIMEDpriMED Medical Products IncFME2025-07-21
00842942009563PRIMEDpriMED Medical Products IncFME2025-07-21
00842942013928PRIMEDpriMED Medical Products IncFME2025-07-21
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
10850045738065UNCThe University of North Carolina Health SystemFME2023-10-31
10810141930473VIVIT SupplyVivit Supply LLCFME2023-09-15
10810141930480VIVIT SupplyVivit Supply LLCFME2023-09-15