MEDLINE

Primary DI
40080196719656
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
MDS138007
Catalog number
MDS138007
Device description
WARMER,HEEL,INFANT,GEL PK,100CS
Published
2025-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MPOInfant heel warmer (chemical heat pack)

Product Code Classifications

CodeDeviceSpecialtyClass
MPOInfant Heel Warmer (Chemical Heat Pack)Physical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30080196719659PackageGS125In Commercial Distribution
40080196719656PackageGS1100In Commercial Distribution
10080196719655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3008019671965930080196719659
4008019671965640080196719656
1008019671965510080196719655

GMDN Terms

TermDefinition
Hot/cold therapy pack, single-useA non-sterile device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material (e.g., silicate-based gel, peat) that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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