PRIMOBoot, Synthetic Sheepskin - Standard

Basic Information

• Brand Name: PRIMOBoot, Synthetic Sheepskin - Standard
• Primary DI: 00810006681314
• Version / Model: BABSS01
• Catalog Number: BABSS01, BABSS01-W
• Company Name: PRIMO INC
• Labeler DUNS: 958758146
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-20
• Public Version: 2
• Public Version Date: 2021-07-22
• Public Version Status: Update
• Public Device Record Key: 851886c5-77a3-4ca9-a7d1-70f9bcf27d35

Device Description

BABSS01 PRIMOBoot, Synthetic Sheepskin - Standard 12/each; BABSS01-W PRIMOBoot w/wedge, Synthetic Sheepskin - Standard 8/each

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMP	Protector, Skin Pressure	General Hospital	880.6450	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42501	Heel protector	A 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.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00810006682755	GS1	case	12	In Commercial Distribution
Primary	00810006681314	GS1
Package	10810006681311	GS1	Case	8	In Commercial Distribution