HEINE GAMMA® GP Practice Kit M-000.09.556

GUDID 04053755136643

Heine Optotechnik GmbH & Co. KG

Aneroid manual sphygmomanometer Aneroid manual sphygmomanometer Aneroid manual sphygmomanometer Aneroid manual sphygmomanometer Aneroid manual sphygmomanometer Aneroid manual sphygmomanometer Aneroid manual sphygmomanometer Aneroid manual sphygmomanometer Aneroid manual sphygmomanometer Aneroid manual sphygmomanometer Aneroid manual sphygmomanometer Aneroid manual sphygmomanometer Aneroid manual sphygmomanometer Aneroid manual sphygmomanometer Aneroid manual sphygmomanometer
Primary Device ID04053755136643
NIH Device Record Key9bbd61d9-b773-4b40-87d7-1b7fc1c15e08
Commercial Distribution StatusIn Commercial Distribution
Brand NameHEINE GAMMA® GP Practice Kit
Version Model Number000
Catalog NumberM-000.09.556
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 Numberfalse
Manufacturing Datetrue
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
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
GS104053755136643 [Primary]

FDA Product Code

DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

Devices Manufactured by Heine Optotechnik GmbH & Co. KG

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
04053755114658 - BETA 200 OTOSCOPE2024-06-28 since 2024-05 in LED version: BETA 200 LED F.O. OTOSCOPE
04053755114696 - K 180 OTOSCOPE2024-06-28 since 2024-05 in LED version: K180 LED OTOSCOPE
04053755119981 - BETA 200 OPHTHALMOSCOPE2024-06-28 since 2024-05 in LED version: BETA 200 LED OPHTHALMOSCOPE
04053755120000 - BETA 200 S OPHTHALMOSCOPE2024-06-28 since 2024-05 in LED version: BETA 200S LED OPHTHALMOSCOPE 2.5V

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