FDA.report

PRIMOBoot, Purple/Black - Standard

Primary DI
10810006681069
Brand
PRIMOBoot, Purple/Black - Standard
Company
PRIMO INC
Model
BAB8
Catalog number
BAB8
Device description
PRIMOBoot, Purple/Black - Standard
Published
2019-02-20
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
FMPProtector, Skin Pressure

Product Code Classifications

CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10810006681069PackageGS113In Commercial Distribution
00810006681062PrimaryGS10

GMDN Terms

TermDefinition
Heel protectorA device that is designed to be worn over the foot to provide a cushion to protect the heel from friction against surfaces and knocks against objects; the toes will protrude and not be protected. It is typically made from soft padded materials and is held in place with bands or straps around the foot or the foot can be slid into it like a sock. It is typically used by persons that have tendencies for skin sores on their heels, are bedridden, or prone to lack of control with their legs causing injury to the heels. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
958758146
Device count
1
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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