FDA.reportPublic FDA data

Intuitive Depth Exchange™ Catheter (IDE)

Primary DI
00860581002660
Brand
Intuitive Depth Exchange™ Catheter (IDE)
Company
Through The Cords, LLC
Model
000294
Device description
Exchange Catheter with intuitive colored depth system, 70 CM, 15 Fr, not made with natural rubber latex, single use, sterile, fits 6.0 and larger ID tubes.
Published
2022-12-07
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

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
00860581002677PackageGS110In Commercial Distribution
00860581002684PackageGS1100In Commercial Distribution
00860581002660PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860581002677008605810026778605810026770860581002677
00860581002684008605810026848605810026840860581002684
00860581002660008605810026608605810026600860581002660

GMDN Terms#

Term, Definition table
TermDefinition
Endotracheal tube guide, single-useA device used to provide guidance when it is necessary to exchange an endotracheal (ET) tube which has been intubated into a patient. The guide is inserted into the existing tube which is then retracted over the guide. The new ET tube is inserted over the guide to facilitate its correct passage, and the guide is removed once the new tube is satisfactorily in place. This is a single-use device.

Regulatory Flags#

DUNS number
080585251
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850059297216Runnels Steerable Introducer™ #4 Oral0010312024-03-22
00850059297063Runnels Steerable Introducer™ #2.5 Oral/Nasal0010912024-10-23
00850059297070Runnels Steerable Introducer™ #2.5 Oral/Nasal0010912024-10-23
00850059297001Runnels Steerable Introducer™ #5 Nasal0010792024-10-22
00850059297032Runnels Steerable Introducer™ #2 Oral/Nasal0010972024-10-22
00850059297094Runnels Steerable Introducer™ #3 Oral/Nasal0010852024-10-22
00850059297124Runnels Steerable Introducer™ DLT (35F/37F)0011092024-10-22
00850059297155Runnels Steerable Introducer™ DLT (39F/41F)0011032024-10-22
00850059297018Runnels Steerable Introducer™ #5 Nasal0010792024-10-22
00850059297049Runnels Steerable Introducer™ #2 Oral/Nasal0010972024-10-22
00850059297100Runnels Steerable Introducer™ #3 Oral/Nasal0010852024-10-22
00850059297131Runnels Steerable Introducer™ DLT (35F/37F)0011092024-10-22
00850059297162Runnels Steerable Introducer™ DLT (39F/41F)0011032024-10-22
00860581002639Total Control Introducer™ (TCI)0001632022-12-07
00850059297186Runnels Steerable Introducer™ #4 Nasal0010502024-01-26
00850059297223Runnels Steerable Introducer™ #4 Oral0010312024-03-22
00850059297193Runnels Steerable Introducer™ #4 Nasal0010502024-01-26
00860006823207TCI™ Si0009462022-12-07
00860006823238Runnels Steerable Introducer™ (rSI)0010312023-06-09
00860581002608Intuitive Depth Bougie™ (IDB), Coude Tip0001182022-12-07

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