FDA.report

MEDZAH INSTANT HOT PACK

Primary DI
20860011917483
Brand
MEDZAH INSTANT HOT PACK
Company
Medzah Industries
Model
SAM-2000
Device description
Instant Hot Pack 6x6 inch
Published
2025-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
IMDPack, Hot Or Cold, Disposable

Product Code Classifications

CodeDeviceSpecialtyClass
IMDPack, Hot Or Cold, DisposablePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20860011917483PackageGS124In Commercial Distribution
10860011917486PrimaryGS10

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(860)288-8696info@medzah.com

Regulatory Flags

DUNS number
114193536
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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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20860011725415BIONEXBNMD052025-07-30
20860011917490MEDZAH INFANT HEEL WARMERSAM-1082025-07-30
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