FDA.reportPublic FDA data

Suction Catheter

Primary DI
06925816656057
Brand
Suction Catheter
Company
Well Lead Medical Co.,Ltd
Model
FN02A060620
Device description
6Fr, T-type connecter
Published
2026-06-03
Public version status
New
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
16925816656054PackageGS1100In Commercial Distribution
26925816656051PackageGS16In Commercial Distribution
06925816656057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1692581665605416925816656054
2692581665605126925816656051
06925816656057069258166560576925816656057

GMDN Terms#

Term, Definition table
TermDefinition
Airway suction catheterA flexible tube designed to be inserted through the mouth, artificial airway, tracheostomy tube, and/or nostrils, for periodic aspiration of liquids and/or semi-solids from a patient's airway (e.g., pharynx, trachea, bronchi, nasal cavity) as part of a suction system; it is not intended to inflate the lungs. It is typically made of polymer with a smooth and rounded distal-tip, often including end and side holes and a finger-controlled valve to regulate suction. This is a single-use device.

Regulatory Flags#

DUNS number
544811862
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06925816673962Wellead Hydrophilic Intermittent Catheter F01L0308302026-04-03
06925816673979Wellead Hydrophilic Intermittent Catheter F01L0310302026-04-03
06925816673986Wellead Hydrophilic Intermittent Catheter F01L0312302026-04-03
06925816673993Wellead Hydrophilic Intermittent Catheter F01L0314302026-04-03
06925816674006Wellead Hydrophilic Intermittent Catheter F01L0316302026-04-03
06925816674013Wellead Hydrophilic Intermittent Catheter F01L0318302026-04-03
06925816674020Wellead Hydrophilic Intermittent Catheter F01L0208202026-04-03
06925816674037Wellead Hydrophilic Intermittent Catheter F01L0210202026-04-03
06925816674044Wellead Hydrophilic Intermittent Catheter F01L0212202026-04-03
06925816674051Wellead Hydrophilic Intermittent Catheter F01L0214202026-04-03
06925816674068Wellead Hydrophilic Intermittent Catheter F01L0216202026-04-03
06925816674075Wellead Hydrophilic Intermittent Catheter F01L0218202026-04-03
06925816674082Wellead Hydrophilic Intermittent Catheter F01L0410302026-04-03
06925816674099Wellead Hydrophilic Intermittent Catheter F01L0412302026-04-03
06925816674105Wellead Hydrophilic Intermittent Catheter F01L0414302026-04-03
06925816674112Wellead Hydrophilic Intermittent Catheter F01L0416302026-04-03
06925816674129Wellead Hydrophilic Intermittent Catheter F01L0418302026-04-03
06925816674136Wellead Hydrophilic Intermittent Catheter F01L0108102026-04-03
06925816674143Wellead Hydrophilic Intermittent Catheter F01L0110102026-04-03
06925816674150Wellead Hydrophilic Intermittent Catheter F01L0112102026-04-03

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
00840117344761Resp-O2 Closed Suction Endotracheal Catheter, Y-Adaptor, InfantDynarex CorporationBSY2026-05-25
00840117344778Resp-O2 Closed Suction Endotracheal Catheter, Elbow, InfantDynarex CorporationBSY2026-05-25
00840117346215Resp-O2 Closed Suction Endotracheal Catheter, Elbow, PediatricDynarex 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