PG-21 PG-21

GUDID 00894912002197

Noninvasive vascular ultrasound system

Primary Device ID	00894912002197
NIH Device Record Key	06b6457f-e998-490b-a85d-5bae8ae45f0d
Commercial Distribution Status	In Commercial Distribution
Brand Name	PG-21
Version Model Number	PG-21
Catalog Number	PG-21
Company DUNS	069261402
Company Name	KOVEN TECHNOLOGY, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
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	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00894912002197 [Primary]

DPW	Flowmeter, Blood, Cardiovascular

Steralize Prior To Use	false
Device Is Sterile	false

00894912002043 - BiDop 3	2023-11-03 Bidirectional Doppler with waveform display.
00894912002197 - PG-21	2023-11-03PPG probe module.
00894912002197 - PG-21	2023-11-03 PPG probe module.
00894912002203 - PGV-20	2023-11-03 PPG and Pulse Volume combo module for Smartdops.
00894912002296 - BF8M15S8A	2023-11-03 8 MHz flat clinic CW Doppler probe.
00894912002302 - BT10M5S8A	2023-11-03 10 MHz straight cable clinic CW Doppler probe.
00894912002319 - BT10M5S8C	2023-11-03 10 MHz curly cable clinic CW Doppler probe.
00894912002333 - BT5M05S8A	2023-11-03 5 MHz straight cable clinic CW Doppler probe.
00894912002340 - BT5M05S8C	2023-11-03 5 MHz curly cable clinic CW Doppler probe.