HEINE GAMMA® GP Practice Kit M-000.09.556

GUDID 04053755136643

Heine Optotechnik GmbH & Co. KG

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

04053755203314 - DELTA X2025-12-11 Set containing contact plates and power supply E4-USB
04053755203321 - DELTA X CPP2025-12-11 contact plate
04053755203338 - DELTA X CPG2025-12-11 contact plate
04053755202744 - BETA X Otoscope2025-07-28 Set containing X CHANGE System 4.2 x Magnifier, 10 x AllSpec 4 mm disposable tips
04053755202973 - FINOFF TRANSILLUMINATOR2025-07-25
04053755202966 - BETA X OPHTHALMOSCOPE2025-07-25
04053755203048 - GAMMA 3.22025-07-25 GAMMA 3.2 ACOUSTIC X-Serie
04053755202928 - DELTAone2025-05-08

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.