AccessGUDID - DEVICE: Giraffe PT Light Meter (07640158711514)

GUDID

Device Identifier (DI) Information

Brand Name: Giraffe PT Light Meter
Version or Model: D16103000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5697449
Company Name: Derungs Licht AG

Primary DI Number: 07640158711514
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 481027886 *Terms of Use

Device Description: Blue light radiometer: An instrument designed to measure the radiant flux (radiant power) in the spectral range of 400 to 500 nm (i.e., blue) during bilirubinemia treatment for newborns and infants

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?
47701	Blue light radiometer	An instrument designed to measure the radiant flux (radiant power) in the spectral range of 400 to 500 nm (i.e., blue) during bilirubinemia treatment for newborns and infants. It typically includes a pre-filter intended to remove wavelengths of light not in the 400-500 nm range (e.g., infrared light); a primary detector consisting of a temperature-stabilized, solid-state [e.g., selenium (Se) or indium-gallium-arsenide] device used to detect radiation; electronic circuits including an amplifier and a electric meter; a power source (e.g., a battery); and a display showing the results either in analogue or digital format.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use

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: 7bb7181a-e8d1-4ac0-94c8-d27271c8924d
Public Version Date: June 30, 2021
Public Version Number: 1
DI Record Publish Date: June 22, 2021