FDA.reportPublic FDA data

AirLife™

Primary DI
30889483606210
Brand
AirLife™
Company
Sunmed Group Holdings, LLC
Model
T60
Catalog number
T60
Device description
AirLife™ Tri-Flo™ Suction Catheter
Published
2025-03-07
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

Contact Domains#

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
30889483606210PackageGS150In Commercial Distribution
10889483606216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088948360621030889483606210
1088948360621610889483606216

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800)433-2797info@sun-med.com

Regulatory Flags#

DUNS number
119058668
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
false
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
30889483569522AirLife™001248U001248U2025-03-28
30889483570566AirLife™0018000018002025-03-28
30889483571914AirLife™0081780081782025-03-28
30889483570474AirLife™0016080016082025-03-27
30889483570559AirLife™0017970017972025-03-27
30889483570573AirLife™0018010018012025-03-27
30889483570597AirLife™0018030018032025-03-27
30889483570603AirLife™0018100018102025-03-27
30889483570658AirLife™0018220018222025-03-27
30889483570665AirLife™0018230018232025-03-27
30889483570672AirLife™0018240018242025-03-27
30889483570689AirLife™0018300018302025-03-27
30889483570863AirLife™0019510019512025-03-27
30889483570887AirLife™0019550019552025-03-27
30889483571679AirLife™0037600037602025-03-27
30889483571686AirLife™0037620037622025-03-27
30889483571693AirLife™0037640037642025-03-27
30889483572119AirLife™0P17750P17752025-03-27
30889483572126AirLife™0P17760P17762025-03-27
30889483572164AirLife™0Y37700Y37702025-03-27

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