FDA.reportPublic FDA data

Safe-Cam Tablet and Accessories

Primary DI
M710NDK2
Brand
Safe-Cam Tablet and Accessories
Company
BIOTEX, INC.
Model
033-5000
Catalog number
SC-NDK
Published
2018-07-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
M710NDK2PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rigid non-bladed video intubation laryngoscopeA non-sterile device intended to facilitate the positioning of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It consists of a thin tubular portion inserted into the ET tube prior to intubation, with an electronic camera at its distal end to transmit anatomical images by a video system to a handle/monitor. It is typically made of memory-alloy material to allow moulding into a shape to facilitate intubation. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure540 millibar1060 millibar
Handling Environment Humidity25 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Atmospheric Pressure540 millibar1060 millibar
Storage Environment Humidity10 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
969792050
Device count
1
Premarket exempt
true
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M710TCW51000Bayou™ troCarWash System Disposable KitTCW-5-1002025-10-10
M710TCW101200Bayou™ troCarWash System Disposable KitTCW-10-1202024-01-31
M71004614002Slide Bite Fork046-1400046-14002025-02-28
M710SCC0Safe-Cam Connecting Cable Assembly033-6500SC-C2018-07-25
M710SCM0Safe-Cam Display Monitor Assembly033-6501SC-M2018-07-25
M710SCMR0Safe-Cam Display Monitor Charger033-6000-003SC-MR2018-07-25
M710SCVS0Safe-Cam Sterile Video Stylet033-1000SC-VS2018-07-25
M710TCWC0Bayou™ troCarWash System ControllerTCW-C2024-01-22
M710WW1D0Wire Watch™WW-1D2024-07-03
M710ERGUIDE10050OcciGuide048-1001ER GUIDE 10052021-02-25
M710ERGUIDE10100OcciGuide048-1000ER GUIDE 10102021-02-25
M710ERGUIDE1010OcciGuideER GUIDE 1010048-10002020-02-20
M71003810000Bayou™ troCarWash System Disposable Kit038-10002023-08-04
M71003850000Bayou™ troCarWash System Controller038-50002023-08-04
M710WW12K0Wire Watch™WW-12K2023-07-31
M71002110010Wire Watch™021-10012023-02-09
M71004615000The Slide®046-15002023-05-19
M71004610000The Slide®046-10002021-09-01
M710ERGUIDE10102OcciGuide048-1000ER GUIDE 10102021-02-25
M710ERGUIDE10052OcciGuide048-1001ER GUIDE 10052021-02-25

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04053755213139MEDUVISION HyMac 3 (10x)Heine Optotechnik GmbH & Co. KGCCW2026-06-23
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00842209139200NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
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