FDA.reportPublic FDA data

PremierPro

Primary DI
00811220033101
Brand
PremierPro
Company
SVS LLC
Model
7606
Catalog number
7606
Device description
Quilted Plus Adult Briefs, Moderate, X-Large, Beige, 15/bg
Published
2020-09-03
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EYQGarment, Protective, For Incontinence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYQGarment, Protective, For IncontinenceGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811220033101PackageGS14In Commercial Distribution
00811220033248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811220033101008112200331018112200331010811220033101
00811220033248008112200332488112200332480811220033248

GMDN Terms#

Term, Definition table
TermDefinition
Incontinence pants, single-useAn underwear designed to retain urine leakage in incontinent adults and older children. It typically consists of a single-use man?s brief or woman?s panty with external softness and shape resembling regular underwear, and an internal pad and/or isolated shell capable of retaining the urine of patients with light or medium incontinence while keeping the skin dry. The device is used in healthcare facilities or at home.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-531-7699info@s2s-global.com

Regulatory Flags#

DUNS number
831375089
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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
00811220035495PremierPro882088202024-10-28
00811220035518PremierPro882188212024-10-28
10811220035430PremierProD5061D50612024-03-08
10811220035447PremierProD5062D50622024-03-08
10811220035454PremierProD5063D50632024-03-08
10811220035461PremierProD5064D50642024-03-08
10811220035478PremierProD5065D50652024-03-08
00811220035143PremierProFL1003DFL1003D2024-02-14
00811220035174PremierProFL1005DFL1005D2024-02-14
00811220035099PremierProFL1010DFL1010D2024-02-14
00811220035112PremierProFL1010SFFL1010SF2024-02-14
00811220034412PremierPro™31T1417531T141752022-12-19
00811220034443PremierPro™31T1617731T161772022-12-19
00811220034474PremierPro™31T1811631T181162022-12-19
00811220034504PremierPro™31T1818831T181882022-12-19
00811220034535PremierPro™31T2011631T201162022-12-19
00811220034566PremierPro™31T2010031T201002022-12-19
00811220034597PremierPro™31T2018831T201882022-12-19
00811220034627PremierPro™31T2210031T221002022-12-19
00811220034658PremierPro™31T2407531T240752022-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00199536910034BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910041BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910058BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910065BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910072BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910089BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910096BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910102BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910119BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910126BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536911109BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536911116BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536911123BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536911130BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536911147BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536911154BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536911161BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
10840330704813ProCureTwin Med, LLCEYQ2026-04-28
10840330704820ProCureTwin Med, LLCEYQ2026-04-28
10840330704837ProCureTwin Med, LLCEYQ2026-04-28
96979303250023CuteleafZhangzhou Win Share Co.,Ltd.EYQ2026-01-12
96979303250030CuteleafZhangzhou Win Share Co.,Ltd.EYQ2026-01-12
96979303250054CuteleafZhangzhou Win Share Co.,Ltd.EYQ2026-01-12
96979303250061CuteleafZhangzhou Win Share Co.,Ltd.EYQ2026-01-12
00199536911048BluelineTransparent Supply Solutions Ltd.EYQ2025-09-22
00199536911055BluelineTransparent Supply Solutions Ltd.EYQ2025-09-22
00199536911062BluelineTransparent Supply Solutions Ltd.EYQ2025-09-22