AtlanticMED

Basic Information

• Brand Name: AtlanticMED
• Primary DI: 00860008614667
• Version / Model: ATL-PER-0613
• Company Name: Atlantic Trading LLC
• Labeler DUNS: 117485067
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-09
• Public Version: 1
• Public Version Date: 2022-11-17
• Public Version Status: New
• Public Device Record Key: ed7b1d68-8a7d-4b1f-9e27-b2795aedc767

Device Description

Perineal Instant Cold Pack. Highly absorbent. Adhesive tab.

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	890.5710	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65127	Perineal cooler	An absorbent device intended to cool the female perineum (the area between the vulva and the anus) by direct contact to provide pain relief and reduce inflammation after labour/childbirth. It is in the form of an absorbent pad with either: 1) an inbuilt pocket of chemicals that generate an endothermic chemical reaction when activated to reduce the temperature of the pad; or 2) an envelope filled with a thermally-retentive material (e.g., silicate-based gel) that can be precooled in a refrigerator/freezer. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860008614667	GS1
Package	10860008614664	GS1	Case	24	In Commercial Distribution