FDA.report

Instant Cold Pack 6inx9in

Primary DI
10860010472146
Company
Medzah Industries
Model
SAM-1001
Device description
Instant Cold Pack 6inx9in 24/cs
Published
2025-08-11
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

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
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
10860010472146PackageGS124In Commercial Distribution
00860010472149PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
10860010472146PackageGS124CASE00860010472149In Commercial Distribution
00860010472149PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
IMDPack, Hot Or Cold, Disposable1Physical Medicine890.5710NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

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.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

No records found.

Other Devices From This Company

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