FDA.report

Vpod

Primary DI
30860013591909
Brand
Vpod
Company
Cool Comforts Co.
Model
VP1
Device description
Personal Disposable Cold Pack used to ease discomfort related to BV, yeast, menopause, and vaginal tearing.
Published
2025-05-02
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

Product Codes

CodeName
IMDPack, Hot Or Cold, Disposable

Product Code Classifications

CodeDeviceSpecialtyClass
IMDPack, Hot Or Cold, DisposablePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20860013591902PackageGS1250In Commercial Distribution
30860013591909PackageGS13In Commercial Distribution
00860013591908PrimaryGS10

GMDN Terms

TermDefinition
Moist-cold packA non-sterile device intended to be temporarily applied to a particular area of the body surface to provide moist cold. It typically consists of a disposable pad/pack/towel that includes an overlapping of several layers of fabric (e.g., gauze, cotton) and is intended to apply moist cold to the tissues after immersion in cold water and freed from excess moisture; it is not a compression bandage. It is typically used for temporary vasoconstriction of superficial blood vessels to help control bleeding, to inhibit inflammation and microbial activity in the early stages of infection, and to prevent/control oedema after strains or contusions. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit70 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
(513) 394-6362info@coolcomforts.co

Regulatory Flags

DUNS number
092544297
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
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 DIBrandModelCatalogPublished
30860013591930Vpod EliteVPE2025-09-24

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