AccessGUDID - DEVICE: Infrascanner (00861606000326)

GUDID

Device Identifier (DI) Information

Brand Name: Infrascanner
Version or Model: 2500
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2500
Company Name: INFRASCAN, INC.

Primary DI Number: 00861606000326
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 153408179 *Terms of Use

Device Description: Handheld Brain Hematoma Detector

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):	No
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?
62661	Near-infrared intracranial haematoma detector	A noninvasive, hand-held, electrically-powered device intended to be used to scan a patient’s head for the detection of an intracranial (e.g., epidural, subdural and intracerebral) haematoma, using near-infrared (NIR) technology. It consists of a control unit which emits an infrared laser, measures reflection with an optical detector, and displays processed results. Typically, the recorded patient data from the scan can be downloaded from the device for further assessment by a medical professional.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OPT	Infrared Hematoma Detector

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200203	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1834d3eb-bcc0-4d57-94c7-cb1f018221d3
Public Version Date: June 22, 2023
Public Version Number: 1
DI Record Publish Date: June 14, 2023

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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