Model 30 Pneumatonometer

GUDID 00812559010979

AC powered contact tonometer intended for the measurement of intraocular pressure (IOP). The device is indicated for use as a screening /monitoring tool for glaucoma or when increased IOP is suspected.

REICHERT, INC.

Ophthalmic tonometer, line-powered
Primary Device ID00812559010979
NIH Device Record Keyaa4be1df-877e-498e-a66b-1b2424938ba5
Commercial Distribution StatusIn Commercial Distribution
Brand NameModel 30 Pneumatonometer
Version Model Number16032
Company DUNS126650253
Company NameREICHERT, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-849-8955
Emailreichert.information@ametek.com
Phone1-888-849-8955
Emailreichert.information@ametek.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100812559010979 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HKXTonometer, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-22

On-Brand Devices [Model 30 Pneumatonometer]

00812559010979AC powered contact tonometer intended for the measurement of intraocular pressure (IOP). The de
00812559010962AC powered contact tonometer intended for the measurement of intraocular pressure (IOP). The de
00812559010955AC powered contact tonometer intended for the measurement of intraocular pressure (IOP). The de

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