PremierPro

Primary DI
00811220032098
Brand
PremierPro
Company
PRESTIGE AMERITECH, LTD.
Model
3869
Catalog number
3869
Device description
Warming Blanket, Pre Warming Gown, Size Small plus Kit1. GENERAL DESCRIPTION · PremierPro™ Multi-functional Warming Blankets 2. CONSTRUCTION · Raw material: Multi-Laminate/ Heat Sealed or Stitched Non-woven Polypropylene fabric · Yellow / Non-Breathable Air Capture Layer – Coated / Low-density polyethylene (LDPE) · White (patient facing) Layer - Perforated to enable passage of air and temperature control · Disposable / Single Patient Use · Not made with natural rubber latex. 3. MRI COMPATIBLE · Non-Metallic / Disposable Patient Warming Blankets are compatible with Magnetic Resonance Imaging equipment The Warming System is indicated for hyper or hypothermic patients or normothermic patients for who induced hyper or hypothermia or localized temperature therapy is clinically indicated. In addition, the Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm.
Published
2019-04-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWJSystem, Thermal Regulating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWJSystem, Thermal RegulatingCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140635000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140635000COCOON CONVECTIVE WARMING SYSTEMCare Essentials Pty, Ltd.2014-07-25DWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10811220032095PackageGS110In Commercial Distribution
00811220032098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081122003209510811220032095
00811220032098008112200320988112200320980811220032098

GMDN Terms#

Term, Definition table
TermDefinition
Blanket warming cabinet, dry-heatA mains electricity (AC-powered) device designed to warm blankets with hot dry air. It is typically a high capacity (e.g., 0.2 to 0.5 m3) unit with appropriate perforated shelves for blanket positioning, avoiding contact with very hot surfaces to prevent scorching. Hot dry air is usually circulated to heat blankets in a temperature range from 30 to 90? C (90 to 200? F).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
199692794
Device count
1
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

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Primary DI, Brand, Company table
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