FDA.reportPublic FDA data

Medline

Primary DI
10888277723771
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJBOUG15
Catalog number
DYNJBOUG15
Device description
BOUGIE, INTRODUCER, 15FRX70CM, COUD
Published
2024-04-24
Public version status
New
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
BSRSTYLET, TRACHEAL TUBE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSRStylet, Tracheal TubeAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888277723778PackageGS110In Commercial Distribution
10888277723771PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088827772377820888277723778
1088827772377110888277723771

GMDN Terms#

Term, Definition table
TermDefinition
Endotracheal tube introducer, single-useA device designed to help with the insertion of an endotracheal (ET) tube into the airways of a patient during intubation. It is a long, thin, rod-like device, typically angled at the distal end, designed to improve directional control of the endotracheal tube during routine or difficult oral intubations. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196180639GeminiGEM1115SGEM1115S2020-12-22
00080196749884MEDLINEMDS149010MDS1490102024-03-05
00080196749891MEDLINEMDS149000MDS1490002021-09-09
10080196418329MEDLINEHCS4482RHCS4482R2021-03-31
10080196418336MEDLINEHCS4483RHCS4483R2020-12-01
10080196715534HUDSON RCIHCS4482HCS44822021-03-31
10080196715565MEDLINEHCS4486HCS44862021-03-31
10888277657625MEDLINEHCSU4483HCSU44832021-10-01
10888277699205MEDLINEHCS4481VTHCS4481VT2021-10-01
10888277699229MEDLINEHCS4483VTHCS4483VT2021-10-01
10888277699236MEDLINE INDUSTRIESHCSU448314HCSU4483142021-10-01
00888277692100MEDLINEHCS4480HCS44802021-05-18
00888277699215MEDLINEHCS448314HCS4483142021-05-18
10080196715541MEDLINEHCS4483HCS44832020-10-28
00888277682033MEDLINEHCSU4482HCSU44822020-08-21
00888277682040MEDLINEHCSU4485HCSU44852020-08-21
10080196259441MedlineMDT013380MDT0133802016-10-14
10080196993819MEDLINEDYND19120DYND191202020-11-12
00080196515939CURADCUR9224CUR92242026-07-06
10197344012039HUDSON RCIHUD1743HUD17432026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851232007165RTech REUSABLE INTUBATION STYLET D R BURTON HEALTHCARE, LLCBSR2026-04-28
00851232007172RTech STERILE DISPOSABLE INTUBATION STYLETD R BURTON HEALTHCARE, LLCBSR2026-04-28
00851232007189RTech NON-STERILE DISPOSABLE INTUBATION STYLETD R BURTON HEALTHCARE, LLCBSR2026-04-28
00851232007196J-WAND ADVANTAGE INTUBATION STYLET, NON-STERILED R BURTON HEALTHCARE, LLCBSR2026-04-28
10889483033302SunMedSUNMED, LLCBSR2026-02-18
10889483033319SunMedSUNMED, LLCBSR2026-02-18
10889483033326SunMedSUNMED, LLCBSR2026-02-18
20889483033309SunMedSUNMED, LLCBSR2026-02-18
20889483033316SunMedSUNMED, LLCBSR2026-02-18
20889483033323SunMedSUNMED, LLCBSR2026-02-18
00848530094676AnesthesiaSUNSET HEALTHCARE SOLUTIONS, INC.BSR2025-12-10
00848530094683AnesthesiaSUNSET HEALTHCARE SOLUTIONS, INC.BSR2025-12-10
00848530094690AnesthesiaSUNSET HEALTHCARE SOLUTIONS, INC.BSR2025-12-10
00848530094706AnesthesiaSUNSET HEALTHCARE SOLUTIONS, INC.BSR2025-12-10
10848530094673AnesthesiaSUNSET HEALTHCARE SOLUTIONS, INC.BSR2025-12-10
10848530094680AnesthesiaSUNSET HEALTHCARE SOLUTIONS, INC.BSR2025-12-10
10848530094697AnesthesiaSUNSET HEALTHCARE SOLUTIONS, INC.BSR2025-12-10
10848530094703AnesthesiaSUNSET HEALTHCARE SOLUTIONS, INC.BSR2025-12-10
04250105630442Ambu® SureSight TM Stylet; mediumVBM Medizintechnik GmbHBSR2025-07-02
04250105630459Ambu® SureSight TM Stylet; largeVBM Medizintechnik GmbHBSR2025-07-02
04250105630435Ambu® SureSight TM Stylet; smallVBM Medizintechnik GmbHBSR2025-07-02
14250105630449Ambu® SureSight TM Stylet; mediumVBM Medizintechnik GmbHBSR2025-07-02
14250105630456Ambu® SureSight TM Stylet; largeVBM Medizintechnik GmbHBSR2025-07-02
05055788776246ProVu Video StyletFLEXICARE MEDICAL LIMITEDBSR2025-05-30
05055788776260ProVu Video StyletFLEXICARE MEDICAL LIMITEDBSR2025-05-30
05055788776284ProVu Video StyletFLEXICARE MEDICAL LIMITEDBSR2025-05-30
05055788776307ProVu Video StyletFLEXICARE MEDICAL LIMITEDBSR2025-05-30
00860004198864Stylet – Tracheal Tube/ Bougie CatheterGMMI SDN. BHD.BSR2025-05-23
10860004198861Stylet – Tracheal Tube/ Bougie CatheterGMMI SDN. BHD.BSR2025-05-23
05030267108763UNIVERSAL STYLET BOUGIE (USB) WITHOUT SACHET OF LUBRICANTIntersurgical IncorporatedBSR2025-03-14