PremierPro

FDA UDI

Class II (US FDA UDI)

by Svs Llc

Identity

Trade Name: PremierPro FDA UDI
Generic Name: Blanket warming cabinet, dry-heat FDA UDI
Device Name: Warming Blanket, Pediatric Child 130 x 92 cm 1. 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. FDA UDI
Model / Reference: 3853 FDA UDI
Description: Warming Blanket, Pediatric Child 130 x 92 cm 1. 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. FDA UDI

Identifiers

Catalog Number: 3853 FDA UDI
Primary DI / UDI-DI: 00811220031954 FDA UDI
FDA Product Code: DWJ FDA UDI
GMDN Term: Blanket warming cabinet, dry-heat FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.5900 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Blanket warming cabinet, dry-heat

PremierPro by Svs Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blanket warming cabinet, dry-heat.

DUAL CHAMBER WARMING CABINET — Mac Medical, Inc. · Class I
COUNTER TOP BLANKET/FLUID WARMER Overall Size 24”W x 26.5”D x 24.5”T — Mac Medical, Inc. · Class I
SINGLE CHAMBER BLANKET/FLUID WARMER Overall Size 30”W x 26.5”D x 36”T — Mac Medical, Inc. · Class I
DUAL CHAMBER BLANKET/FLUID WARMING CABINET Overall Size 30”W x 26.5”D x 74.5”T — FUTURE HEALTH CONCEPTS, INC. · Class I
DUAL CHAMBER BLANKET / FLUID WARMER Overall Size 30”W x 26.5”D x 74.5”T — Mac Medical, Inc. · Class I
SINGLE CHAMBER BLANKET/FLUID WARMER Overall Size 30”W x 20.5”D x 36”T — Mac Medical, Inc. · Class I
COUNTER TOP/WALL MOUNT SINGLE CHAMBER WARMER, 18 X 15.5 X 22 — Mac Medical, Inc. · Class I
WARMER, SINGLE CHAMBER — Mac Medical, Inc. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Svs Llc

Sources (1)

FDA UDI d04dc325-da92-45cc-8e1c-abe54a0ae629 35 fields · synced May 31, 2026