visionPRO HR1 Mac

GUDID 04053755199907

Heine Optotechnik GmbH & Co. KG

Video intubation laryngoscope handle/monitor
Primary Device ID04053755199907
NIH Device Record Key75a28a23-cef1-4d3f-90a3-97389efe5d7d
Commercial Distribution StatusIn Commercial Distribution
Brand NamevisionPRO HR1 Mac
Version Model Number000
Company DUNS315274563
Company NameHeine Optotechnik GmbH & Co. KG
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (603) 742-7103
Emailservice@heine-na.com
Phone+1 (603) 742-7103
Emailservice@heine-na.com
Phone+1 (603) 742-7103
Emailservice@heine-na.com
Phone+1 (603) 742-7103
Emailservice@heine-na.com
Phone+1 (603) 742-7103
Emailservice@heine-na.com
Phone+1 (603) 742-7103
Emailservice@heine-na.com
Phone+1 (603) 742-7103
Emailservice@heine-na.com
Phone+1 (603) 742-7103
Emailservice@heine-na.com
Phone+1 (603) 742-7103
Emailservice@heine-na.com
Phone+1 (603) 742-7103
Emailservice@heine-na.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104053755199907 [Primary]

FDA Product Code

CCWLaryngoscope, Rigid

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-14
Device Publish Date2022-11-04

Devices Manufactured by Heine Optotechnik GmbH & Co. KG

04053755179206 - BETA 400 LED F.O. OTOSCOPE2024-08-14
04053755201853 - visionPRO Mac 22024-08-14
04053755202423 - MINI3000 LED OTOSCOPE 2024-08-14 available also in blue
04053755202508 - BETA 200 LED RETINOSCOPE2024-07-24
04053755191673 - BETA 200 LED RETINOSCOPE2024-07-17 3,5 V
04053755186556 - BETA 200 LED VET. OTOSCOPE2024-07-05
04053755202133 - K180 LED F.O. OTOSCOPE 2024-07-05
04053755202232 - K 180 LED OPHTHALMOSCOPE2024-07-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.