FDA.report

AirLife™

Primary DI
30889483584129
Brand
AirLife™
Company
Sunmed Group Holdings, LLC
Model
4682A
Catalog number
4682A
Device description
Tracheostomy Cleaning Tray
Published
2025-02-20
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

Related Records

Contact Domains

Product Codes

CodeName
OFPAnesthesia Breathing Circuit Kit (Adult & Pediatric)

Product Code Classifications

CodeDeviceSpecialtyClass
OFPAnesthesia Breathing Circuit Kit (Adult & Pediatric)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30889483584129PackageGS120In Commercial Distribution
10190752142008PreviousGS10
10889483584125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3088948358412930889483584129
1019075214200810190752142008
1088948358412510889483584125

GMDN Terms

TermDefinition
Tracheostomy care kit, single-useA collection of sterile devices and supplies intended to be used for the maintenance of a tracheostomy (i.e., removal and cleaning of tracheostomy tube prior to reinsertion). It typically includes towels, gauze, swabs, cleaning brush, and gloves. This is a single-use device.

Sterilization Methods

Method

Contacts

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 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 DIBrandCompanyProduct codePublished
00850070635035Breathing Circuit KitNar Medical Depot, LLCOFP2025-12-01
50198956137248CARDINAL HEALTHCardinal Health 200, LLCOFP2025-08-11
04048675695622Anesthesia Circuit Kit Coax HEPADrägerwerk AG & Co. KGaAOFP2025-05-19
04048675695639Anesthesia Circuit Kit Flex HEPADrägerwerk AG & Co. KGaAOFP2025-05-19
0503026716154622mm Compact breathing systemIntersurgical IncorporatedOFP2025-04-14
0503026716175122mm Compact breathing systemIntersurgical IncorporatedOFP2025-04-14
10889483583388Vital Signs™AirLife Finland OyOFP2025-04-14
10889483587072Vital Signs™AirLife Finland OyOFP2025-04-14
10889483587089Vital Signs™AirLife Finland OyOFP2025-04-14
10889483587096Vital Signs™AirLife Finland OyOFP2025-04-14
10889483587102Vital Signs™AirLife Finland OyOFP2025-04-14
10889483587119Vital Signs™AirLife Finland OyOFP2025-04-14
10889483587126Vital Signs™AirLife Finland OyOFP2025-04-14
10889483590072Vital Signs™AirLife Finland OyOFP2025-04-14
00816472022972Multipac UniFlow anesthesia breathing systemIntersurgical IncorporatedOFP2025-04-11
10841470106215ABC -Flex Tube SystemENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470106260ABC - Uniflow Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470106284ABC - Duoflow Bi-lumen Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470106345ABC - Flex Tube SystemENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470106574ABC - Compact Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470106581ABC - Compact Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470106734ABC - Duoflow Bi-lumen Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470107113ABC - Uniflow Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470107656ABC - Uniflow Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470108622ABC - Flex Tube SystemENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470108738ABC - Duoflow Bi-lumen Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470108844ABC - Pediatric Compact Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470108943ABC - Duoflow Bi-lumen Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470108950ABC - Pediatric Compact Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470109452ABC - Compact Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11