FDA.reportPublic FDA data

PremierPro

Primary DI
10818566017915
Brand
PremierPro
Company
SVS LLC
Model
6613PP
Catalog number
6613PP
Device description
Premium Quilted Ultra Underpad, Maximum Absorbency, Clothlike, 30" x 36", 10/bg
Published
2020-09-08
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
KMEBedding, Disposable, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818566017915PackageGS14In Commercial Distribution
00818566017918PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081856601791510818566017915
00818566017918008185660179188185660179180818566017918

GMDN Terms#

Term, Definition table
TermDefinition
Absorbent underpad, non-antimicrobialA flat piece of absorbent fabric material [e.g., non-woven polyethylene (PE), cellulose] intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids resulting from surgical procedures, childbirth and/or incontinence; it does not include an antimicrobial agent(s). It is intended to be used in the healthcare facility and in the home. This is a single-use device.

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
16931918186184InvenioGRI Medical & Electronic Technology Co., Ltd.KME2026-04-29
10304040196660Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196677Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196684Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196691Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196707Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196714Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
16931918105475AllesetGRI Medical & Electronic Technology Co., Ltd.KME2026-03-18
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCKME2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCKME2025-11-19
M68959120030Hypothermia Management SetSafeguard US Operating, LLCKME2025-10-24
10304040193157Henry ScheinHENRY SCHEIN, INC.KME2025-09-03
20192253014423CARDINAL HEALTHCardinal Health 200, LLCKME2025-08-19
16931918194165AllesetGRI Medical & Electronic Technology Co., Ltd.KME2025-06-21
16931918129815HALYARDGRI Medical & Electronic Technology Co., Ltd.KME2025-06-20
10889483602911AirLife™AirLife Finland OyKME2025-04-17
10889483602928AirLife™AirLife Finland OyKME2025-04-17
10889483602935AirLife™AirLife Finland OyKME2025-04-17
10889483602942AirLife™AirLife Finland OyKME2025-04-17
10889483603031AirLife™AirLife Finland OyKME2025-04-17
10889483603048AirLife™AirLife Finland OyKME2025-04-17
10603354120669ComfortTopEHOB INCKME2025-01-22
M68959320040HAWK Advanced Hypothermia Management SetSafeguard US Operating, LLCKME2024-10-08
16931918123400AllesetGRI Medical & Electronic Technology Co., Ltd.KME2024-09-05
16931918177564AllesetGRI Medical & Electronic Technology Co., Ltd.KME2024-09-05
16931918177984AllesetGRI Medical & Electronic Technology Co., Ltd.KME2024-09-05
07613327632835Sage Multi-Position MATSSAGE PRODUCTS, LLCKME2024-08-12
10850053289580SURGYCOSurgyco LLCKME2024-08-09
16931918115214HALYARDGRI Medical & Electronic Technology Co., Ltd.KME2024-06-11
16931918121987HALYARDGRI Medical & Electronic Technology Co., Ltd.KME2024-06-11