FDA.report

NOVAPLUS

Primary DI
20192253061465
Brand
NOVAPLUS
Company
Cardinal Health 200, LLC
Model
V11460-010
Catalog number
V11460-010
Device description
NovaPlus Infant Heel Warmer with tape
Published
2023-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

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
20192253061465PackageGS125In Commercial Distribution
50192253061466PackageGS14In Commercial Distribution
10192253061468PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019225306146520192253061465
5019225306146650192253061466
1019225306146810192253061468

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

TypeValueUnit
Height4Inch
Width4Inch

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature040 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
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
true
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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