PRIMO

GUDID 00840216121638

HEEL PROTECTOR, SHEEPSKIN, W/PADDED STRAP, UNIVERSAL, 1PR/BG, 12BG/CS

Asp Global, LLC

Foot cushion Foot cushion Foot cushion Foot cushion Foot cushion Foot cushion Foot cushion Foot cushion Foot cushion Foot cushion Foot cushion Foot cushion Foot cushion Foot cushion Foot cushion Foot cushion Foot cushion Foot cushion

• Primary Device ID: 00840216121638
• NIH Device Record Key: eec94d83-0c95-451e-9f02-145e8160ec51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRIMO
• Version Model Number: HPS004
• Company DUNS: 080361159
• Company Name: Asp Global, LLC
• 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: false
• Lot Batch: false
• 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	00840216121638 [Primary]

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: 2024-01-24
• Device Publish Date: 2024-01-16

On-Brand Devices [PRIMO]

• 00840216118331: PRIMOBoot, Burn - Standard (Purple/Navy)
• 00840216118027: PRIMOBoot, Burn - Standard
• 00840216117914: PRIMOBoot, Red/Gray - Standard
• 00840216117907: PRIMOBOOT, BLACK/GRAY, STANDARD
• 00840216115125: PRIMO BOOT, KELLY GREEN/NAVY, STANDARD, 13EA/CS
• 00840216114807: PRIMO BOOT - PURPLE AND BLACK, 1/EA,13/CS
• 00840216114791: PRIMO BOOT - GOLD AND NAVY, 1/EA,13/CS
• 00840216114357: PRIMO BOOT, NAVY/GRAY, BARIATRIC, 10EA/CS
• 00840216114340: PRIMO BOOT, PURPLE/GRAY, SMALL, 13EA/CS
• 00840216114333: PRIMO BOOT, KELLY GREEN/NAVY, STANDARD, 13EA/CS
• 00840216114227: PRIMOBoot, Diabetic - Small (w/wedge)
• 00840216114166: Medstar Franklin PRIMOBoot (Custom) - Standard (w/wedge)
• 00840216113879: PRIMOBoot, Fall Risk - Bariatric (w/wedge)
• 00840216113862: PRIMOBoot, Fall Risk - Standard (w/wedge)
• 00840216113855: PRIMOBoot, Fall Risk - Small (w/wedge)
• 00840216113848: PRIMOBoot, Diabetic - Bariatric (w/wedge)
• 00840216113831: PRIMOBoot, Diabetic - Bariatric
• 00840216113824: PRIMOBoot, Diabetic - Small
• 00840216113497: PRIMOBoot, Black/Gray - Small (w/wedge)
• 00840216113480: PRIMOBoot, Red/Navy - Child
• 00840216113473: PRIMO BOOT - NAVY AND GREY, 1/EA,13/CS
• 00840216113442: Anti-Rotational Wedge for HeelShield, Green
• 00840216113435: Anti-Rotational Wedge for PRIMOBoot & HeelCheck, Black
• 00840216113343: PRIMOBoot, Diabetic - Standard
• 00840216113336: PRIMOBoot, Fall Risk - Bariatric
• 00840216113329: PRIMOBoot, Fall Risk - Small
• 00840216113312: PRIMOBoot, Fall Risk - Standard
• 00840216113305: PRIMOBoot, Burn - Standard (Purple/Navy)
• 00840216113299: PRIMOBoot, Navy/Gray - Bariatric
• 00840216113282: PRIMOBoot, Black/Gray - Small
• 00840216113275: PRIMOBoot, Purple/Gray - Small
• 00840216113268: PRIMOBoot, Purple/Navy - Standard
• 00840216113251: PRIMOBoot, Kelly Green/Navy - Standard
• 00840216113244: PRIMOBoot, Navy/Gray - Standard
• 00840216113237: PRIMOBoot, Black/Khaki - Standard
• 00840216113152: PRIMOBoot, Burn - Bariatric (w/wedge)
• 00840216113145: PRIMOBoot, Burn - Small (w/wedge)
• 00840216113138: PRIMOBoot, Burn - Standard (w/wedge)
• 00840216113008: ANTI-ROTATIONAL WEDGE, BLACK, SMALL, 1EA/BG, 24BG/CS
• 00840216112926: PRIMOBOOT, BLACK & GRAY, W/WEDGE, SMALL, 1SET/BG, 8BG/CS
• 00840216112919: PRIMOBOOT, PURPLE & NAVY, W/WEDGE, STANDARD, 1SET/BG, 8BG/CS
• 00840216112889: PRIMOBOOT GREEN/NAVY W/WEDGE, STANDARD, 1SET/BG, 8BG/CS
• 00840216112865: PRIMOBOOT, BURN, NAVY & NAVY, BARIATRIC, 1EA/BG, 10BG/CS
• 00840216112841: PRIMOBOOT, BURN, PURPLE & NAVY, SMALL, 1EA/BG, 13BG/CS
• 00840216119482: Economy Synthetic Sheepskin Elbow Protector
• 00840216118140: Guardian Mid-Calf Heel Protector, Purple/Navy
• 00840216118133: Guardian Heel Protector, Navy/Gray
• 00840216118126: Heel/Elbow Protector - XLarge (knitted w/foam)
• 00840216118119: Heel/Elbow Protector - Small (knitted w/foam)
• 00840216118102: Heel/Elbow Protector - Medium (knitted w/foam)