AccessGUDID - DEVICE: FaceLake (00851908007161)

GUDID

Device Identifier (DI) Information

Brand Name: FaceLake
Version or Model: FD-300B
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LORTE TECHNOLOGIES, INC

Primary DI Number: 00851908007161
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 029578633 *Terms of Use

Device Description: The FD-300B is a ultrasonic Doppler that allows expectant mothers and health care professionals to retrieve and listen to the fetal heart rate.

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?
34040	Foetal Doppler system	A portable, hand-held, battery-powered device assembly consisting of a measuring and display unit and an attached probe or interchangeable probes designed to noninvasively detect foetal heart beats using ultrasound/Doppler technology. The heart beats are typically conveyed audibly via the measuring/display unit and attached probe which is applied to the surface of the pregnant woman's abdomen. The device aids in determining foetal viability.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNG	Monitor, Ultrasonic, Fetal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K082480	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 9f359dca-b765-485a-bae5-89801bd5d6f5
Public Version Date: July 06, 2018
Public Version Number: 2
DI Record Publish Date: March 21, 2018