FDA.reportPublic FDA data

PRIMED

Primary DI
00842942013461
Brand
PRIMED
Company
priMED Medical Products Inc
Model
PM1-3345
Device description
CSR Wrap, Single Sheet, Purple, P300, 45in x 45in
Published
2026-05-29
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
FRGWrap, Sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10842942013468PackageGS12In Commercial Distribution
00842942013461PrimaryGS10
90842942013464Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084294201346810842942013468
00842942013461008429420134618429420134610842942013461
9084294201346490842942013464

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

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
50
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
false
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
00842942012990PRIMEDPM1-31122026-05-29
00842942013003PRIMEDPM1-31152026-05-29
00842942013010PRIMEDPM1-31182026-05-29
00842942013027PRIMEDPM1-31202026-05-29
00842942013034PRIMEDPM1-31242026-05-29
00842942013041PRIMEDPM1-31302026-05-29
00842942013058PRIMEDPM1-31362026-05-29
00842942013065PRIMEDPM1-31402026-05-29
00842942013072PRIMEDPM1-31452026-05-29
00842942013089PRIMEDPM1-31482026-05-29
00842942013096PRIMEDPM1-31542026-05-29
00842942013102PRIMEDPM1-31722026-05-29
00842942013188PRIMEDPM1-32152026-05-29
00842942013195PRIMEDPM1-32182026-05-29
00842942013201PRIMEDPM1-32242026-05-29
00842942013218PRIMEDPM1-32302026-05-29
00842942013225PRIMEDPM1-32362026-05-29
00842942013232PRIMEDPM1-32402026-05-29
00842942013249PRIMEDPM1-32482026-05-29
00842942013256PRIMEDPM1-32722026-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842942012990PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013003PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013010PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013027PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013034PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013041PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013058PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013065PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013072PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013089PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013096PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013102PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013188PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013195PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013201PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013218PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013225PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013232PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013249PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013256PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013423PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013430PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013447PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013454PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013478PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013607PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013614PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013621PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013638PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013737PRIMEDpriMED Medical Products IncFRG2026-05-29