KetoBM

GUDID 00860015091642

Multiple clinical chemistry analyte monitoring system IVD, home-use

Primary Device ID	00860015091642
NIH Device Record Key	8fd00ca6-a973-43d1-9655-c33c7f332b4d
Commercial Distribution Status	In Commercial Distribution
Brand Name	KetoBM
Version Model Number	KBM-KCL1
Company DUNS	119625339
Company Name	KETOBM USA LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	true

Device Issuing Agency	Device ID
GS1	00860015091642 [Primary]

JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)

Steralize Prior To Use	false
Device Is Sterile	false

00860015091666	Blood Glucse Control Solution - Level 2
00860015091659	Blood Glucose Control Solution - Level 1
00860015091642	Blood Ketone Control Solution - Level 1

Mark Image Registration \| Serial	Company Trademark Application Date
KETOBM 88267714 not registered Live/Pending	KetoBM LLC 2019-01-18