FDA.report

CVS Health

Primary DI
10050428387891
Brand
CVS Health
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
162619
Device description
Back & Hip Heat Wrap L-XL 5 Ct
Published
2020-08-07
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
IMDPack, Hot Or Cold, Disposable

Product Code Classifications

CodeDeviceSpecialtyClass
IMDPack, Hot Or Cold, DisposablePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10050428387891PackageGS124In Commercial Distribution
00050428387894PrimaryGS10
60050428387896Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1005042838789110050428387891
00050428387894000504283878940504283878940050428387894
6005042838789660050428387896

GMDN Terms

TermDefinition
Exothermic heat therapy pack/patchA device intended to be applied to the body surface, sometimes with pressure, to provide heat therapy to reduce muscle spasms and cramps and/or for joint and muscle stiffness and pain. It includes an envelope(s) filled with a material that produces an exothermic chemical reaction when activated; it may be available in a variety of forms (e.g., adhesive patch, belt containing packs). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
18007467287xx@xx.xx

Regulatory Flags

DUNS number
062312574
Device count
5
DM exempt
false
Premarket exempt
true
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

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