FDA.reportPublic FDA data

PRIMED

Primary DI
00842942018718
Brand
PRIMED
Company
priMED Medical Products Inc
Model
PM4-99455XL
Device description
AAMI 2 Chemotherapy Drug Tested Isolation Gown, Hook & Loop, Knit Cuff, Full Back, XL, Blue
Published
2026-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FYCGown, Isolation, Surgical
QSOMedical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYCGown, Isolation, SurgicalGeneral, Plastic Surgery2
QSOMedical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy DrugsGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10842942018715PackageGS16In Commercial Distribution
00842942018718PrimaryGS10
90842942018711Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084294201871510842942018715
00842942018718008429420187188429420187180842942018718
9084294201871190842942018711

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in cool, dry, and well ventilated space out of direct sunlight.

Regulatory Flags#

DUNS number
253287569
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842942018596PRIMEDPM4-994552026-10-23
00842942011047PRIMEDPM4-571932025-07-15
00842942013386PRIMEDPM1-23452026-05-15
00842942001888PRIMEDPG4-16802025-07-14
00842942003806PRIMEDPG4-16402025-07-14
00842942007910PRIMEDPG4-25012025-07-14
00842942008467PRIMEDPM4-58493XL2025-07-15
00842942011788PRIMEDPM4-581932025-07-15
00842942012389PRIMEDPG4-19212025-07-14
00842942015700PRIMEDPM4-571922025-07-17
00842942015717PRIMEDPM4-57192XL2025-07-17
00842942016530PRIMEDPM4-581922025-07-21
00842942017230PRIMEDPM4-68374XL2025-07-15
00842942017261PRIMEDPM4-571912025-07-17
00842942017278PRIMEDPM4-57191XL2025-07-17
00842942017483PRIMED / CaracalCPS10732025-11-20
05391534524441PRIMEDPM4-57372C2025-07-15
00842942008894PRIMEDPG4-49932026-06-21
00842942013485PRIMEDPM1-33542026-06-04
00842942013645PRIMEDPM1-34242026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842942018596PRIMEDpriMED Medical Products IncQSO2026-10-23
00842942018596PRIMEDpriMED Medical Products IncFYC2026-10-23
00813360021475ProtexerICP MEDICAL, LLCFYC2025-08-15
10813360021472ProtexerICP MEDICAL, LLCFYC2025-08-15
00813360021468ProtexerICP MEDICAL, LLCFYC2025-08-08
00688162000030ProtexerICP MEDICAL, LLCFYC2025-08-08
00688162290004ProtexerICP MEDICAL, LLCFYC2025-08-08
00688162390506ProtexerICP MEDICAL, LLCFYC2025-08-08
10813360021465ProtexerICP MEDICAL, LLCFYC2025-08-08
00813360021772ProtexerICP MEDICAL, LLCFYC2025-08-08
00842942015175PRIMEDpriMED Medical Products IncFYC2025-07-21
00842942015304PRIMEDpriMED Medical Products IncFYC2025-07-21
10842942015172PRIMEDpriMED Medical Products IncFYC2025-07-21
10842942015301PRIMEDpriMED Medical Products IncFYC2025-07-21
04719882251399CopioumedCOPIOUMED INTERNATIONAL INC.QSO2025-07-16
04719882251399CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251412CopioumedCOPIOUMED INTERNATIONAL INC.QSO2025-07-16
04719882251412CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251436CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251436CopioumedCOPIOUMED INTERNATIONAL INC.QSO2025-07-16
04719882251450CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251450CopioumedCOPIOUMED INTERNATIONAL INC.QSO2025-07-16
04719882251559CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251559CopioumedCOPIOUMED INTERNATIONAL INC.QSO2025-07-16
04719882251573CopioumedCOPIOUMED INTERNATIONAL INC.QSO2025-07-16
04719882251573CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251597CopioumedCOPIOUMED INTERNATIONAL INC.QSO2025-07-16
04719882251597CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251610CopioumedCOPIOUMED INTERNATIONAL INC.QSO2025-07-16
04719882251610CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16