FDA.reportPublic FDA data

SourceMark

Primary DI
00813799006074
Brand
SourceMark
Company
SOURCEMARK, LLC.
Model
M1028
Published
2020-07-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BTQAirway, Nasopharyngeal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTQAirway, NasopharyngealAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10813799006088PackageGS110In Commercial Distribution
20813799006092PackageGS110In Commercial Distribution
00813799006074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081379900608810813799006088
2081379900609220813799006092
00813799006074008137990060748137990060740813799006074

GMDN Terms#

Term, Definition table
TermDefinition
Nasopharyngeal airway, single-useA rubber or plastic tube that extends into the pharynx from either naris to maintain airway patency. The proximal end of the device may have an integral 22 mm connector for oxygen delivery. This is a single-use device.

Regulatory Flags#

DUNS number
121225812
Device count
1
Premarket exempt
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
00813799000003SourceMark M09062020-07-07
00813799000034SourceMark M09082020-07-07
00813799000065SourceMark M09102020-07-07
00813799000096SourceMark M0912 2020-07-07
00813799000126SourceMark M09142020-07-07
00813799007354SourceMark M09062020-11-06
00813799007385SourceMark M09082020-11-06
00813799007415SourceMark M09102020-11-06
00813799007446SourceMark M09122020-11-06
00813799007477SourceMark M09142020-11-06
00897392001322SourceMark M09142016-08-26
00897392001339SourceMark M09102016-08-26
00897392001346SourceMark M09062016-08-26
00813799005084SourceMark M1205 2020-07-09
00813799002748SourceMark CV3WF2022-02-24
00813799002861SourceMark CV1002022-02-24
00813799002878SourceMark CVST12022-02-24
08973920006501KozeeM210012020-01-27
08973920006518KozeeM210022020-01-27
08973920006525KozeeM210032020-01-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840118618298Endure IndustriesENDURE INDUSTRIESBTQ2026-08-14
00840118618304Endure IndustriesENDURE INDUSTRIESBTQ2026-08-14
00840118618311Endure IndustriesENDURE INDUSTRIESBTQ2026-08-14
00840118618328Endure IndustriesENDURE INDUSTRIESBTQ2026-08-14
00840118618335Endure IndustriesENDURE INDUSTRIESBTQ2026-08-14
00840118618342Endure IndustriesENDURE INDUSTRIESBTQ2026-08-14
14026704930187RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930194RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930200RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930217RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930224RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930231RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930248RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930255RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930262RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930279RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930286RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930514RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930521RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930538RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930545RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930552RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930569RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930576RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930583RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930590RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930606RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930613RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930620RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28
14026704930637RUSCHTELEFLEX INCORPORATEDBTQ2026-07-28