AtlanticMED

GUDID 00860008614605

INFANT HEEL WARMER, 12 X 8.5 CM, 57 G, PE

Atlantic Trading LLC

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• Primary Device ID: 00860008614605
• NIH Device Record Key: c6d1d052-76e8-47f5-8b5e-500e32fc2e0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AtlanticMED
• Version Model Number: ATL-IFW-0305
• Company DUNS: 117485067
• Company Name: Atlantic Trading LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860008614605 [Primary]
GS1	10860008614602 [Package]; Package: Inner case [25 Units]; In Commercial Distribution
GS1	20860008614609 [Package]; Package: Outer Carton [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053254

FDA Product Code

• MPO: Infant Heel Warmer (Chemical Heat Pack)

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: 2022-11-17
• Device Publish Date: 2022-11-09

On-Brand Devices [AtlanticMED]

• 00860008614667: Perineal Instant Cold Pack. Highly absorbent. Adhesive tab.
• 00860008614650: RESUSABLE GEL PACK, 12 X 29 CM, 350 G, PE & NYLON
• 00860008614643: INSTANT COLD PACK, 15.3 X22.9 CM, 237 G, PE & NYLON
• 00860008614636: INSTANT COLD PACK, 12.7 X 15.3 CM, 109 G, PE & NYLON
• 00860008614629: INSTANT HOT PACK, 15.3 X22.9 CM, 237 G, PE & NYLON
• 00860008614612: INSTANT HOT PACK, 12.7 X 15.3 CM, 109 G, PE & NYLON
• 00860008614605: INFANT HEEL WARMER, 12 X 8.5 CM, 57 G, PE
• 10860008614671: Surgical N95 Respirator, NIOSH Approved, Berry-Compliant, Made-in-the-USA