FDA.reportPublic FDA data

Barrier® EasyWarm®

Primary DI
07333350154653
Brand
Barrier® EasyWarm®
Company
Mölnlycke Health Care AB
Model
629905
Device description
EasyWarm, ACTIVE SELF-WARMING BLANKET, 92x152 cm
Published
2024-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
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
K232508000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232508000Barrier EasyWarm Active Self-Warming BlanketMolnlycke Health Care Us, LLC2023-09-15DWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07333350154653PackageGS110In Commercial Distribution
07333350371685PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07333350154653073333501546537333350154653
07333350371685073333503716857333350371685

GMDN Terms#

Term, Definition table
TermDefinition
Activated-medium surgical warming blanketA non-sterile device intended to help prevent a patient from cooling prior to, during, and after a surgical intervention by serving as a heat-generating cover. It is a highly hygienic device made of plastic material and designed with integrated pockets that hold air-activated warming pads containing various media [e.g., active coal, clay, or salt and iron (Fe) powder] that chemically generate heat when the device is removed from its sealed packaging. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+46737733775pedro.lopes@molnlycke.com

Regulatory Flags#

DUNS number
631770658
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07333350377205Mepore®3319002026-05-23
07333350625993Mepore®3320002026-05-23
07333350050498Mestopore®6651002026-05-06
07333350065126Mepore® Pro6711202026-05-06
07333350436575Mepore® Pro6811402026-05-06
07333350477103Mepore® Pro6713202026-05-06
07333350627041Mepore® Pro6712202026-05-06
07333350862176Mepore® Pro6709202026-05-06
07333350872489Mepore®6715002026-05-06
07333350904104Mestopore®6650002026-05-06
07333350917159Mepore® Pro6710202026-05-06
07333350976712Tubigrip®14362026-05-06
07333350996147Mepore®6709702026-05-06
05060097937790Biogel® PI408552022-10-21
05060097937806Biogel® PI408602022-10-21
05060097937813Biogel® PI408652022-10-21
05060097937820Biogel® PI408702022-10-21
05060097937837Biogel® PI408752022-10-21
05060097937844Biogel® PI408802022-10-21
05060097937851Biogel® PI408852022-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09332017002991CocoonCARE ESSENTIALS PTY LTDDWJ2026-04-29
09332017004131CocoonCARE ESSENTIALS PTY LTDDWJ2026-02-25
09332017004155CocoonCARE ESSENTIALS PTY LTDDWJ2026-02-25
10197344129072MEDLINEMEDLINE INDUSTRIES, INC.DWJ2025-05-07
10197344129089MEDLINEMEDLINE INDUSTRIES, INC.DWJ2025-05-07
08719867002639Mistral-AirThe Surgical Company International B.V.DWJ2025-01-30
08719867002653Mistral-AirThe Surgical Company International B.V.DWJ2025-01-30
09332017002861CocoonCARE ESSENTIALS PTY LTDDWJ2024-12-20
09332017003257CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003295CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003301CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003318CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003325CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003332CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003349CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
08719867002646Mistral-Air®The Surgical Company International B.V.DWJ2024-07-08
08719867002660Mistral-Air®The Surgical Company International B.V.DWJ2024-07-08
10193489134773MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10193489134780MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10193489134797MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10197344012770MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10197344012817MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10197344012831MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10197344013401MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10197344012794MedlineMEDLINE INDUSTRIES, INC.DWJ2024-04-30
09332017002885CocoonCARE ESSENTIALS PTY LTDDWJ2023-01-20
09332017002892CocoonCARE ESSENTIALS PTY LTDDWJ2023-01-20
09332017000645CocoonCARE ESSENTIALS PTY LTDDWJ2021-08-04
09332017002168CocoonCARE ESSENTIALS PTY LTDDWJ2021-08-04
09332017001178CocoonCARE ESSENTIALS PTY LTDDWJ2021-06-01