FDA.reportPublic FDA data

TenderTip

Primary DI
05056038303458
Brand
TenderTip
Company
GBUK LTD
Model
TT04-12-E56
Catalog number
TT04-12-E56
Device description
TenderTip, Suction Catheter, Closed, Single Use Endotracheal 12Fr x 56cm
Published
2023-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
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
05056038303458PackageGS125In Commercial Distribution
05056038303465PackageGS12In Commercial Distribution
05056038303441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056038303458050560383034585056038303458
05056038303465050560383034655056038303465
05056038303441050560383034415056038303441

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
738810980
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
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
05060405747462BananaB-ASSISTB-ASSIST2023-06-02
05060405746830BananaPATPAQ-DGF100200PATPAQ-DGF1002002023-06-02
05060405746854BananaPATPAQ-DGF100200/HPATPAQ-DGF100200/H2023-06-02
05060405744928BananaB-VERSAL-SPUHB-VERSAL-SPUH2023-06-02
05060405748353BananaEGF100220EGF1002202025-02-28
05060405748384BananaDGF100220DGF1002202025-02-28
05060405748414BananaEGT100220EGT1002202025-02-28
05060405748445BananaDGT100220DGT1002202025-02-28
05060405748476BananaEGF100220HEGF100220H2025-02-28
05060405748506BananaDGF100220HDGF100220H2025-02-28
05060405748612BananaB-EGT100220-PB-EGT100220-P2025-02-28
05060405748636BananaLGF100220LGF1002202025-02-28
05060405748667BananaLGF100220HLGF100220H2025-02-28
05060405748698BananaLGT100220LGT1002202025-02-28
05060405748728BananaPATPAQ-EGF140200PATPAQ-EGF1402002025-02-28
05060405748346BananaEGF100220EGF1002202025-02-28
05060405748391BananaDGF100220DGF1002202025-02-28
05060405748421BananaEGT100220EGT1002202025-02-28
05060405748438BananaDGT100220DGT1002202025-02-28
05060405748483BananaEGF100220HEGF100220H2025-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196033553MEDLINEMEDLINE INDUSTRIES, INC.BSY2026-05-15
10850014574878Pepper Medical Closed SuctionPEPPER MEDICAL INC.BSY2025-09-15
10850014574892Pepper Medical Closed SuctionPEPPER MEDICAL INC.BSY2025-09-15
10850014574915Pepper Medical Closed SuctionPEPPER MEDICAL INC.BSY2025-09-15
10850014574922Pepper Medical Closed SuctionPEPPER MEDICAL INC.BSY2025-09-15
10850014574854Pepper Medical Closed SuctionPEPPER MEDICAL INC.BSY2025-09-11
10850014574953Pepper Medical Closed SuctionPEPPER MEDICAL INC.BSY2025-09-11
10850014574977Pepper Medical Closed SuctionPEPPER MEDICAL INC.BSY2025-09-11
10850014574991Pepper Medical Closed SuctionPEPPER MEDICAL INC.BSY2025-09-11
10850014574014Pepper Medical Closed SuctionPEPPER MEDICAL INC.BSY2025-09-11
10850014574038Pepper Medical Closed SuctionPEPPER MEDICAL INC.BSY2025-09-11
10850014574052Pepper Medical Closed SuctionPEPPER MEDICAL INC.BSY2025-09-11
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
10704411012740AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012757AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012764AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012771AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012825AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012832AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012849AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012856AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012863AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23
10704411012870AMSure® Closed Suction System for AdultsAMSINO INTERNATIONAL, INC.BSY2025-06-23