FDA.reportPublic FDA data

Sensorendo

Primary DI
06974723790026
Brand
Sensorendo
Company
Sensorendo Medical Technology (Zhuhai) Co., Ltd.
Model
S-VLB
Device description
S-VLB Laryngoscope blade
Published
2023-01-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRCInstrument, Ent Manual Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16974723790092PackageGS112In Commercial Distribution
06974723790026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697472379009216974723790092
06974723790026069747237900266974723790026

GMDN Terms#

Term, Definition table
TermDefinition
Video intubation laryngoscope bladeA rigid, blade-like component of a bladed video intubation laryngoscope intended to be inserted 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 an electronic camera at its distal end to transmit anatomical images by a video system to a connected video intubation laryngoscope handle/monitor. This is a single-use device.

Sterilization Methods#

Method table
Method
Liquid Chemical

Contacts#

Phone, Email table
PhoneEmail
+8613602561980min@sensorendo.com

Regulatory Flags#

DUNS number
722337994
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974723790033SensorendoS-VLB2024-05-17
06974723795953SensorendoDP102023-12-27
16974723795950SensorendoDP102023-12-27
06974723796011SensorendoS-DVL2023-12-14
06974723791115SensorendoS-RVL2022-11-11
06974723792112SensorendoS-VL-012022-11-11
06974723793119SensornedoS-VL-R2022-11-11
06974723794413SensorendoS-FVL2022-11-11

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00190776419950MillenniumAvalign Technologies, Inc.LRC2026-04-15
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00190776418977MillenniumAvalign Technologies, Inc.LRC2026-04-13
00198506089954ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-03
00198506089497ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-02