AccessGUDID - DEVICE: Medline (00888277707958)

GUDID

Device Identifier (DI) Information

Brand Name: Medline
Version or Model: SHNOTOUCH
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SHNOTOUCH
Company Name: MEDLINE INDUSTRIES, INC.

Primary DI Number: 00888277707958
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 025460908 *Terms of Use

Device Description: CTM THERMOMETER, FOREHEAD, NO TOUCH

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:	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?
17888	Infrared patient thermometer, skin	A hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLL	Thermometer, electronic, clinical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K122221	000

Device Exempt from Premarket Submission: No 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 -4 and 104 Degrees Fahrenheit
Special Storage Condition, Specify: Keep dry, Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b6f30cdc-11c5-413f-8015-9b509553ece5
Public Version Date: February 28, 2024
Public Version Number: 2
DI Record Publish Date: December 24, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10888277707955	80	00888277707958		In Commercial Distribution	CS
20888277707952	10	10888277707955		In Commercial Distribution	BX

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

[?]

Phone: +1(800)633-5463
Email: service@medline.com

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