FDA.reportPublic FDA data

NA

Primary DI
00887517055644
Brand
NA
Company
Nuvasive, Inc.
Model
2010870
Device description
EMG ET Tube, 7mm ID Long Elec ENT Kit
Published
2018-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSKCuff, tracheal tube, inflatable
BTRTube, tracheal (w/wo connector)
PDQNeurosurgical nerve locator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSKCuff, Tracheal Tube, InflatableAnesthesiology2
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2
PDQNeurosurgical Nerve LocatorEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133530000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133530000NUVASIVE EMG ENDOTRACHEAL TUBENu Vasive, Incorporated2014-05-02PDQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517055644PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517055644008875170556448875170556440887517055644

GMDN Terms#

Term, Definition table
TermDefinition
Neurophysiologic monitoring systemAn assembly of mains electricity (AC-powered) devices designed to monitor and provide electrical stimuli to spinal nerves or other neural pathways (may include the brain) during intraoperative surgery or intensive care, typically to reduce the incidence of accidental injury during instrumented spine surgery, or to diagnose acute dysfunction in corticospinal conduction (e.g., due to traction, shearing, laceration, compression, or vascular insufficiency). It typically displays electroencephalogram (EEG), electromyogram (EMG), and/or evoked responses. It typically includes an electric current pulse generator, electrodes and/or probes, and audible and/or visual indicators.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(858)909-1800RA_UDI@nuvasive.com
+1800-475-9131nuvainfo@globusmedical.com

Regulatory Flags#

DUNS number
053950783
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887517127693MaXcess707042270704222026-07-27
00887517065100ACP18008223180082232026-04-25
00887517065124ACP18008312180083122026-04-25
00887517065162ACP18008316180083162026-04-25
00887517065186ACP18008318180083182026-04-25
00887517065384ACP18008512180085122026-04-25
00887517065612ACP18008622180086222026-04-25
00887517065643ACP18009117180091172026-04-25
00887517065667ACP18009119180091192026-04-25
00887517065681ACP18009121180091212026-04-25
00887517065926ACP18009229180092292026-04-25
00887517100412VuePoint897711589771152026-04-25
00887517156297ReLine11010511110105112026-04-25
00887517156822ReLine11010530110105302026-04-25
00887517378828CoRoent685121768512172026-04-25
00887517413673MAS PLIF707004270700422026-04-25
00887517645135CoRoent680050868005082026-04-25
00887517645142CoRoent680051068005102026-04-25
00887517645166CoRoent680051468005142026-04-25
00887517645173CoRoent680150868015082026-04-25

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14026704934802LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDBTR2026-08-03
14026704759191SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
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14026704759443SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
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14026704759498SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759504SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
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14026704759597SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759696SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
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14026704759580SHERIDANTELEFLEX INCORPORATEDBTR2026-07-29
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