PRIMO

GUDID 00840216124516

GLIDE & GUIDE TURN SYSTEM INCLUDES 1 EA 56"X70" TURN SHEET PLUS W/ TOP AND BOTTOM HANDLES, 2 EA 15" ANGLED WEDGES W

Asp Global, LLC

Freestanding patient positioner, reusable

• Primary Device ID: 00840216124516
• NIH Device Record Key: 88206428-e1d1-4957-9f57-c0d1d11752fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRIMO
• Version Model Number: GGTS14-5-K
• 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	00840216124516 [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: 2024-03-13
• Device Publish Date: 2024-03-05

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)