AccessGUDID - DEVICE: My PAK, Child (00856767008366)

GUDID

Device Identifier (DI) Information

Brand Name: My PAK, Child
Version or Model: 02803RD
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 02803RD
Company Name: Altitude Technologies Inc.

Primary DI Number: 00856767008366
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 621904622 *Terms of Use

Device Description: Chinook designed My PAK™ Child, Red, to be lightweight and portable with enough room to hold essential medical supplies along with prescribed medications to treat pre-existing conditions, such as serious allergies, asthma, diabetes or heart conditions.

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:	Yes
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?
44039	First aid kit, medicated	A convenient collection of equipment, materials and pharmaceuticals intended to be used in an emergency for the rapid, initial treatment of an injury. It is typically used by emergency medical services (EMS), hospitals, institutions, schools, and other public settings. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRR	First Aid Kit With Drug

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: ba8062c5-f5f5-4987-89f1-530033837090
Public Version Date: June 13, 2023
Public Version Number: 3
DI Record Publish Date: May 19, 2020