FDA.report

AirLife™

Primary DI
30889483570306
Brand
AirLife™
Company
Sunmed Group Holdings, LLC
Model
001427
Catalog number
001427
Device description
Corrugated Flexible Polyethylene and EVA Tubing
Published
2025-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
BZOSet, Tubing And Support, Ventilator (W Harness)

Product Code Classifications

CodeDeviceSpecialtyClass
BZOSet, Tubing And Support, Ventilator (W Harness)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30889483570306PackageGS11In Commercial Distribution
10190752116818PreviousGS10
10889483570302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3088948357030630889483570306
1019075211681810190752116818
1088948357030210889483570302

GMDN Terms

TermDefinition
Oxygen administration tubingA length of flexible noninvasive tube, typically a small bore, thick-walled, anti-kink tubing (to prevent blockage) intended for the delivery of a pure oxygen (O2), or an O2 enriched gas, to a mask or nasal cannula (not included), during delivery of dry O2 to the patient. The tubing is typically available in standard coil lengths and is cut by clinical staff to appropriate lengths to create an extension or connecting piece. 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
true
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 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
20197344011343HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
20197344011350HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
20197344011374HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
44710810100329N/AGALEMED CORPORATIONBZO2026-03-05
44710810107311N/AGALEMED CORPORATIONBZO2026-03-04
04719894389189VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2026-01-28
04719894389196VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2026-01-28
04719894389202VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2026-01-28
09420012479112F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479136F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479150F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479174F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
46923980106406N/AGaleMed Xiamen Co., Ltd.BZO2026-01-22
46923980106413N/AGaleMed Xiamen Co., Ltd.BZO2026-01-22
46923980106420N/AGaleMed Xiamen Co., Ltd.BZO2026-01-22
14719894389162VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2026-01-20
04719894389172VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2026-01-20
20889483225650AirLife™SUNMED, LLCBZO2025-12-19
44710810088405N/AGALEMED CORPORATIONBZO2025-12-18
14719894386314VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2025-08-01
14719894386321VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2025-08-01
14719894386338VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2025-08-01
14719894386345VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2025-08-01
14719894386352VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2025-08-01
14719894386369VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2025-08-01
14719894386376VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2025-08-01
14719894386383VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2025-08-01
14719894386390VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2025-08-01
44026704388781HUDSON RCITELEFLEX INCORPORATEDBZO2025-07-30
24026704388794HUDSON RCITELEFLEX INCORPORATEDBZO2025-07-30