Guardian Heel Protector HP201SS

GUDID 00810006683134

Guardian Heel Protector, Black/Sheepskin

PRIMO INC

Heel protector

• Primary Device ID: 00810006683134
• NIH Device Record Key: dca1da27-e627-42fc-bb61-3063e12cd01e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guardian Heel Protector
• Version Model Number: HP201SS
• Catalog Number: HP201SS
• Company DUNS: 958758146
• Company Name: PRIMO INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810006681895 [Primary]
GS1	00810006683134 [Package]; Contains: 00810006681895; Package: CASE [12 Units]; In Commercial Distribution

FDA Product Code

• FMP: Protector, Skin Pressure

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-20

On-Brand Devices [Guardian Heel Protector]

• 00810006683134: Guardian Heel Protector, Black/Sheepskin
• 00810006683127: Guardian PREEMIE Heel Protector, Purple/Navy
• 00810006683110: Guardian Heel Protector, Purple/Navy
• 00810006680898: Guardian FALL RISK Heel Protector, Yellow
• 00810006680881: Guardian Heel Protector, Navy/Gray
• 00810006680874: Guardian Heel Protector, Black/Khaki