FDA.reportPublic FDA data

Resp-O2 Closed Suction Endotracheal Catheter, Elbow, Pediatric

Primary DI
00840117346215
Brand
Resp-O2 Closed Suction Endotracheal Catheter, Elbow, Pediatric
Company
Dynarex Corporation
Model
31063
Device description
Diameter: 3.3 mm (10 Fr), Length: 16", Length: 40.5 cm
Published
2026-05-25
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
00840117346192PackageGS12In Commercial Distribution
00840117346208PackageGS110In Commercial Distribution
00840117346215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117346192008401173461928401173461920840117346192
00840117346208008401173462088401173462080840117346208
00840117346215008401173462158401173462150840117346215

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
00840117309210Resp-O2 Suction Tubing Combo Pack, Non-Sterile321002021-04-22
00840117309234Resp-O2 Suction Connecting Tubing, Non-Conductive321032021-04-22
00840117309258Resp-O2 Suction Connecting Tubing, Non-Conductive321042021-04-22
00840117309272Resp-O2 Suction Connecting Tubing, Non-Conductive321062021-04-22
00840117309296Resp-O2 Suction Connecting Tubing, Non-Conductive321072021-04-22
00840117309371Resp-O2 Suction Connecting Tubing, Non-Conductive321112021-04-22
00840117309395Resp-O2 Suction Connecting Tubing, Non-Conductive321122021-04-22
00840117313651Resp-O2 Suction Connecting Tubing, Non-Conductive321052021-04-22
00840117309418Resp-O2 Yankauer Suction Handle, Bulb Tip, Vented,321202022-05-10
00840117309432Resp-O2 Yankauer Suction Handle, Bulb Tip, Non-Vented321212022-05-10
00840117309456Resp-O2 Yankauer Suction Handle, Straight Tip, Vented321222022-05-10
00840117309319Resp-O2 Suction Connecting Tubing, Non-Conductive321082022-05-09
00840117309326Resp-O2 Suction Connecting Tubing, Non-Conductive321092022-05-09
00840117309357Resp-O2 Suction Connecting Tubing, Non-Conductive321102022-05-09
00840117309494Resp-O2 Yankauer Suction Handle, Bulb Tip, Non-Vented321262022-05-09
00840117309470Resp-O2 Yankauer Suction Handle, Straight Tip, Non-Vented321232022-04-21
00840117313675Resp-O2 Yankauer Suction Handles, Bulb Tip, Non-Vented321252022-04-21
00840117313699Resp-O2 Yankauer Suction Handle, Bulb Tip, Non-Vented321272022-04-21
00840117313712Resp-O2 Yankauer Suction Handle, Bulb Tip, Non-Vented321282022-04-21
00840117321748Resp-O2 Suction Connecting Tubing, Non-Sterile321012022-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719874954611Create BiotechCREATE BIOTECH CO., LTD.BSY2026-07-16
04719874957667Create BiotechCREATE BIOTECH CO., LTD.BSY2026-07-16
04719874958459Create BiotechCREATE BIOTECH CO., LTD.BSY2026-07-16
10889483564134BALLARD™SUNMED, LLCBSY2026-07-09
06925816656057Suction CatheterWell Lead Medical Co.,LtdBSY2026-06-03
00840117344761Resp-O2 Closed Suction Endotracheal Catheter, Y-Adaptor, InfantDynarex CorporationBSY2026-05-25
00840117344778Resp-O2 Closed Suction Endotracheal Catheter, Elbow, InfantDynarex CorporationBSY2026-05-25
00840117344204Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, T-Piece, PediatricDynarex CorporationBSY2026-05-18
00840117344211Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, T-Piece, Adult/PediatricDynarex CorporationBSY2026-05-18
00840117344228Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, T-Piece, AdultDynarex CorporationBSY2026-05-18
00840117344242Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, Double Swivel Elbow (DSE)Dynarex CorporationBSY2026-05-18
00840117344259Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, Double Swivel Elbow (DSE)Dynarex CorporationBSY2026-05-18
00840117344266Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, Double Swivel Elbow (DSE)Dynarex CorporationBSY2026-05-18
00840117344747Resp-O2 Closed Suction Tracheal Catheter, Elbow, InfantDynarex CorporationBSY2026-05-18
00840117344754Resp-O2 Closed Suction Tracheal Catheter, Elbow, PediatricDynarex CorporationBSY2026-05-18
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
00840117344174Resp-O2 Vexta72 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)Dynarex CorporationBSY2026-01-05
00840117344181Resp-O2 Vexta72 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)Dynarex 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