FDA.reportPublic FDA data

MEDUVISION Set Mac

Primary DI
04053755213092
Brand
MEDUVISION Set Mac
Company
Heine Optotechnik GmbH & Co. KG
Model
000
Catalog number
WM 10411
Published
2026-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
CCWLaryngoscope, Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04053755213092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053755213092040537552130924053755213092

GMDN Terms#

Term, Definition table
TermDefinition
Video intubation laryngoscope handle/monitorA non-sterile component of a bladed video intubation laryngoscope intended to enable the positioning of the blade into the oral cavity to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It has a monitor for the user to view anatomical images of the larynx/trachea transmitted by a video system from an electronic camera at the distal end of the blade. This is a reusable device.

Regulatory Flags#

DUNS number
315274563
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04053755207596GAMMA 3.2 VET000G-000.09.9472026-07-22
04053755200122visionPRO Set Mac000F-270.95.8622026-06-24
04053755213108MEDUVISION Mac 3 (10x)000WM 104132026-06-23
04053755213115MEDUVISION Mac 2 (10x)000WM 104122026-06-23
04053755213122MEDUVISION Mac 4 (10x)000WM 104142026-06-23
04053755213139MEDUVISION HyMac 3 (10x)000WM 104152026-06-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971355350147BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350154BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350161BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350178BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350512BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350529BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350888BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
00190776427580MillenniumAvalign Technologies, Inc.CCW2026-08-26
00190776427597MillenniumAvalign Technologies, Inc.CCW2026-08-26
00190776427603MillenniumAvalign Technologies, Inc.CCW2026-08-26
00190776427610MillenniumAvalign Technologies, Inc.CCW2026-08-26
00198506094071ELMED INCORPORATEDELMED INCORPORATEDCCW2026-08-18
00190776422936MillenniumAvalign Technologies, Inc.CCW2026-08-03
14026704760548PILLINGTELEFLEX INCORPORATEDCCW2026-07-31
25056094503100PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
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