FDA.reportPublic FDA data

Resp-O2 Vexta72 Closed Suction Tracheal Catheter, T-Piece, Pediatric

Primary DI
00840117344129
Brand
Resp-O2 Vexta72 Closed Suction Tracheal Catheter, T-Piece, Pediatric
Company
Dynarex Corporation
Model
31004
Device description
Diameter: 3.3 mm (10FR), Length: 12", Length: 30.5 cm
Published
2025-10-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BSYCatheters, Suction, Tracheobronchial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSYCatheters, Suction, TracheobronchialAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117343795PackageGS12In Commercial Distribution
00840117343955PackageGS110In Commercial Distribution
00840117344129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117343795008401173437958401173437950840117343795
00840117343955008401173439558401173439550840117343955
00840117344129008401173441298401173441290840117344129

GMDN Terms#

Term, Definition table
TermDefinition
Tracheobronchial suction/insufflation catheter, single-lumenA sterile flexible tube designed for periodic tracheal and pharyngeal mucus aspiration and inflation of the lungs with a flow of gas from its distal tip. It consists of a single lumen tube for alternating suction and insufflation. This is a single-use device.

Regulatory Flags#

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117305571Resp-O2 (HEPA) Respiratory BV Filter304012021-04-22
00840117305595Resp-O2 Universal 6" Flex Tube, Connector: 15F/22F306002021-04-22
00840117305618Resp-O2 Tracheostomy Adult Flex Connector 15mmOD x 22mmOD/15mmID306012021-04-22
00840117305632Resp-O2 Tracheostomy Flex Connector, 15 mm OD x 15 mm ID306022021-04-22
00840117305670Resp-O2 Closed Suction Tracheal Catheters, T-Piece, Adult/Pediatric310012021-04-22
00840117305694Resp-O2 Closed Suction Tracheal Catheter, T-Piece, Adult310022021-04-22
00840117305717Resp-O2 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)310102021-04-22
00840117305731Resp-O2 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)310112021-04-22
00840117305755Resp-O2 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)310122021-04-22
00840117305861Resp-O2 Advantage Respiratory B/V Filter304002021-04-22
00840117319462Resp-O2 Closed Suction Tracheal Catheter, T-Piece, Adult310032021-04-22
00840117319486Resp-O2 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)310132021-04-22
00840117319547Resp-O2 Closed Suction Tracheal Catheters, T-Piece, Pediatric310002021-04-22
00840117344136Resp-O2 Vexta72 Closed Suction Tracheal Catheter, T-Piece, Adult/Pediatric310052026-01-05
00840117344143Resp-O2 Vexta72 Closed Suction Tracheal Catheter, T-Piece, Adult310062026-01-05
00840117344167Resp-O2 Vexta72 Closed Suction Tracheal Catheter310142026-01-05
00840117305311Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1000301042021-04-22
00840117305335Resp-O2 Hygroscopic Condenser Humidifier HMEF 1500301052021-04-22
00840117305359Resp-O2 Hygroscopic Condenser Humidifier HMEF 1500301062021-04-22
00840117305373Resp-O2 Hygroscopic Condenser Humidifier HMEF 600301072021-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10889483564134BALLARD™SUNMED, LLCBSY2026-07-09
06925816656057Suction CatheterWell Lead Medical Co.,LtdBSY2026-06-03
10080196033553MEDLINEMEDLINE INDUSTRIES, INC.BSY2026-05-15
00840117344136Resp-O2 Vexta72 Closed Suction Tracheal Catheter, T-Piece, Adult/PediatricDynarex CorporationBSY2026-01-05
00840117344143Resp-O2 Vexta72 Closed Suction Tracheal Catheter, T-Piece, AdultDynarex CorporationBSY2026-01-05
00840117344167Resp-O2 Vexta72 Closed Suction Tracheal CatheterDynarex CorporationBSY2026-01-05
10889483564325BALLARD™SUNMED, LLCBSY2025-11-20
10889483564615BALLARD™SUNMED, LLCBSY2025-11-20
10889483564622BALLARD™SUNMED, LLCBSY2025-11-20
10889483564653BALLARD™SUNMED, LLCBSY2025-11-20
10889483564721BALLARD™SUNMED, LLCBSY2025-11-20
10889483564738BALLARD™SUNMED, LLCBSY2025-11-20
10889483564837BALLARD™SUNMED, LLCBSY2025-11-20
10889483564844BALLARD™SUNMED, LLCBSY2025-11-20
10889483564868BALLARD™SUNMED, LLCBSY2025-11-20
10889483623411BALLARD™SUNMED, LLCBSY2025-11-20
10889483623527BALLARD™SUNMED, LLCBSY2025-11-20
10889483623534BALLARD™SUNMED, LLCBSY2025-11-20
10889483623589BALLARD™SUNMED, LLCBSY2025-11-20
10889483564523BALLARD™SUNMED, LLCBSY2025-11-19
10889483564769BALLARD™SUNMED, LLCBSY2025-11-19
10889483564585BALLARD™SUNMED, LLCBSY2025-11-18
10704411012665AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012672AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012689AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012696AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012702AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012719AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012726AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012733AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23