FDA.reportPublic FDA data

PremierPro

Primary DI
00811220030070
Brand
PremierPro
Company
PRESTIGE AMERITECH, LTD.
Model
1240PP
Catalog number
1240PP
Device description
PremierPro Cold Therapy Unit
Published
2020-09-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILOPack, Hot Or Cold, Water Circulating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILOPack, Hot Or Cold, Water CirculatingPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811220030070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811220030070008112200300708112200300700811220030070

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-fluid thermal therapy system control unitA mains electricity (AC-powered) device intended to be used as part of a circulating-fluid thermal therapy system to pump heated and/or cooled fluid (e.g., water) through an externally applied pack (not included) for localized hot and/or cold therapy for the skin and/or underlying tissues (e.g., muscle) in the treatment of musculoskeletal pain and discomfort. It includes a fluid pump and either a heater, or a means for cold therapy (e.g., refrigeration unit, permitting addition of independently cooled ice water) or both; it does not include an air pump for wrap inflation. It is intended for use in both professional and home settings.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry, Keep Away From Sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-531-7699udi@s2s-global.com

Regulatory Flags#

DUNS number
199692794
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811220035433PremierProD5061D50612024-03-08
00811220035440PremierProD5062D50622024-03-08
00811220035457PremierProD5063D50632024-03-08
00811220035464PremierProD5064D50642024-03-08
00811220035471PremierProD5065D50652024-03-08
00852212003269ProKidsFM85030-CCM12016-09-26
00852212003344ProGearFM85011-CCM12016-09-26
00852212003214ProKidsFM850302016-09-26
00852212003801ProGear7410E32026-04-21
00852212003788PrestigePro24512026-03-27
00852212003795PrestigePro24532026-03-27
00818566016454PremierPro24512016-07-15
00818566019783PremierPro24532020-04-28
20818566017479PremierPro531153112020-07-15
20818566017486PremierPro531253122020-07-15
00811220030001PremierPro6604PP6604PP2020-09-08
00811220030018PremierPro6605PP6605PP2020-09-08
00811220030032PremierPro24922020-04-28
00811220030049PremierPro881788172020-08-29
00811220030056PremierPro881888182020-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812120004895Game Ready* SystemAvanos Medical, Inc.ILO2026-07-31
00812120005076Game Ready* Full Leg Boot Wrap, MediumAvanos Medical, Inc.ILO2026-07-31
00812120005113Game Ready* Ankle Wrap, LargeAvanos Medical, Inc.ILO2026-07-31
00812120005120Game Ready* Ankle Wrap, Extra LargeAvanos Medical, Inc.ILO2026-07-31
00812120005137Game Ready* Shoulder Wrap, Medium, RightAvanos Medical, Inc.ILO2026-07-31
00812120005144Game Ready* Shoulder Wrap, Medium, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005151Game Ready* Shoulder Wrap, Large, RightAvanos Medical, Inc.ILO2026-07-31
00812120005168Game Ready* Shoulder Wrap, Large, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005175Game Ready* Back WrapAvanos Medical, Inc.ILO2026-07-31
00812120005182Game Ready* C-T Spine Wrap, LargeAvanos Medical, Inc.ILO2026-07-31
00812120005199Game Ready* Hip/Groin Wrap, RightAvanos Medical, Inc.ILO2026-07-31
00812120005205Game Ready* Hip/Groin Wrap, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005212Game Ready* Hand/Wrist WrapAvanos Medical, Inc.ILO2026-07-31
00812120005229Game Ready* Flexed Elbow WrapAvanos Medical, Inc.ILO2026-07-31
00812120005236Game Ready* Half Leg Boot WrapAvanos Medical, Inc.ILO2026-07-31
00812120005243Game Ready* Full Leg Boot Wrap, LargeAvanos Medical, Inc.ILO2026-07-31
00812120005250Game Ready* Straight Knee SleeveAvanos Medical, Inc.ILO2026-07-31
00812120005267Game Ready* Articulated Knee SleeveAvanos Medical, Inc.ILO2026-07-31
00812120005274Game Ready* Straight Elbow SleeveAvanos Medical, Inc.ILO2026-07-31
00812120005281Game Ready* Ankle Sleeve, LargeAvanos Medical, Inc.ILO2026-07-31
00812120005298Game Ready* Ankle Sleeve, Extra LargeAvanos Medical, Inc.ILO2026-07-31
00812120005304Game Ready* Shoulder Sleeve, Medium, RightAvanos Medical, Inc.ILO2026-07-31
00812120005311Game Ready* Shoulder Sleeve, Medium, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005328Game Ready* Shoulder Sleeve, Large, RightAvanos Medical, Inc.ILO2026-07-31
00812120005335Game Ready* Shoulder Sleeve, Large, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005342Game Ready* Back SleeveAvanos Medical, Inc.ILO2026-07-31
00812120005359Game Ready* C-T Spine Sleeve, LargeAvanos Medical, Inc.ILO2026-07-31
00812120005366Game Ready* Hip/Groin Sleeve, RightAvanos Medical, Inc.ILO2026-07-31
00812120005373Game Ready* Hip/Groin Sleeve, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005380Game Ready* Hand/Wrist SleeveAvanos Medical, Inc.ILO2026-07-31