AccessGUDID - DEVICE: AtlanticMED (00860008614667)

GUDID

Device Identifier (DI) Information

Brand Name: AtlanticMED
Version or Model: ATL-PER-0613
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Atlantic Trading LLC

Primary DI Number: 00860008614667
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117485067 *Terms of Use

Device Description: Perineal Instant Cold Pack. Highly absorbent. Adhesive tab.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IMD	Pack, Hot Or Cold, Disposable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ed7b1d68-8a7d-4b1f-9e27-b2795aedc767
Public Version Date: November 17, 2022
Public Version Number: 1
DI Record Publish Date: November 09, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10860008614664	24	00860008614667		In Commercial Distribution	Case

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: Yes CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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