AccessGUDID - DEVICE: heat it for iPhone (04262370293123)

GUDID

Device Identifier (DI) Information

Brand Name: heat it for iPhone
Version or Model: 00003IN
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Kamedi GmbH

Primary DI Number: 04262370293123
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315161593 *Terms of Use

Device Description: Smartphone add-on for the symptomatic treatment of insect bites with heat.

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":	No
For Single-Use:	No
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?
47103	Insect bite/sting hyperthermia device	A portable, electrically-powered device intended to be used for the external surface treatment of insect bites or stings (e.g., from midges/gnats, mosquitoes, wasps, hornets, horseflies) through the topical application of concentrated heat. The heat (around 50° Celsius) works to minimize or prevent itching, and may prevent subsequent swelling. It may be either a self-contained hand-held unit or an attachment for a smartphone. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IRT	Pad, Heating, Powered

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
Storage Environment Temperature: between -13 and 158 Degrees Fahrenheit
Handling Environment Temperature: between 41 and 104 Degrees Fahrenheit
Storage Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Handling Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ab8f27d9-f3d0-42df-9c45-cbb6f1bd980f
Public Version Date: September 21, 2022
Public Version Number: 1
DI Record Publish Date: September 13, 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
No Package DIs found

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: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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