FDA.reportPublic FDA data

HEINE® EN 200 Wall Transformer

Primary DI
04053755191482
Brand
HEINE® EN 200 Wall Transformer
Company
Heine Optotechnik GmbH & Co. KG
Model
166
Catalog number
X-095.12.250
Published
2017-11-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HLJOphthalmoscope, Battery-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLJOphthalmoscope, Battery-PoweredOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04053755191482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053755191482040537551914824053755191482

GMDN Terms#

Term, Definition table
TermDefinition
General physical examination setA collection of hand-held devices, battery-powered but may include manual, intended to be used by a physician to help perform parts of a general physical examination of a patient [i.e., ear/nose/throat (ENT) and ophthalmic examinations, blood pressure measurements, temperature] commonly conducted in a primary care setting. The devices (e.g., aneroid sphygmomanometer, otoscope, ophthalmoscope, electronic thermometer) are typically housed within a line-powered charging station (e.g., desktop, wall-mounted) or carry case, which may include accessories (e.g., ear specula, spare light bulbs). This is a reusable device that may contain some disposable devices.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)643-6275support@midmark.com

Regulatory Flags#

DUNS number
315274563
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04053755203567BETA X VET OPHTHALMOSCOPE000G-140.28.3302026-03-31
04053755203574BETA X VET OTOSCOPE000G-130.28.3302026-03-31
04053755207541XV4 BETA X VET SPECULUM4 MMG-000.21.3202026-03-31
04053755207558XV6 BETA X VET SPECULUM6 MMG-000.21.3212026-03-31
04053755207565X CHANGE SYSTEM SL-MAGNIFIER 000G-000.21.2202026-03-31
04053755180172HEINE SIGMA®250000C-008.33.3402016-09-24
04053755180738HEINE SIGMA®250000C-008.33.3412016-09-24
04053755202690DELTA 30 UV002026-03-02
04053755203314DELTA XLEDK-130.28.3302025-12-03
04053755203321DELTA X CPP00K-000.34.2372025-12-03
04053755203338DELTA X CPG00K-000.34.2382025-12-03
04053755202904BETA X Otoscope3xB-130.28.3302025-07-18
04053755202911BETA X Otoscope4.2 xB-131.28.3302025-07-18
04053755202744BETA X Otoscope4.2 xB-131.28.3302025-07-18
04053755203031BETA X OPHTHALMOSCOPELEDC-130.28.3302025-07-17
04053755202973FINOFF TRANSILLUMINATOR2,5 VC-001.17.0802025-07-17
04053755202966BETA X OPHTHALMOSCOPELEDC-130.28.3302025-07-17
04053755203048GAMMA 3.2000M-000.09.9472025-07-17
04053755202928DELTAoneBLACK WHITE EDITIONK-214.28.3052025-04-30
04053755136988GAMMA 3.1000M-000.09.9412022-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M368122731LabtronGF HEALTH PRODUCTS, INC.HLJ2020-09-22
M368122741LabtronGF HEALTH PRODUCTS, INC.HLJ2020-09-22
00192896009509HEINE - BETA R HANDLESONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009516HEINE - LITHIUM ION BATTERYSONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009523HEINE MPACK MINI SONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009530HEINE MPACK LL BATTERY PACK SONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009547HEINE MPACK UNPLUGGED BATTERYSONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009554HEINE MPACK UNPLUGGED BATTERYSONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009561HEINE HC 50 CONNECTING CORDSONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009578HEINE MPACK SONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009585HEINE MPACK COMPLETESONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009592HEINE LI-ION BATTERY SONTEC INSTRUMENTS, INC.HLJ2018-08-24
00634782089221Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-19
00634782089238Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-19
00634782089252Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-19
00634782089276Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-19
00634782089290Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-19
00634782089313Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-19
00634782089320Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-19
00634782088910Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088934Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088941Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088958Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088965Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088972Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088989Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088996Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782087753Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782087760Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782087784Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12