FDA.report

AirLife™

Primary DI
10889483583395
Brand
AirLife™
Company
Sunmed Group Holdings, LLC
Model
428040008
Catalog number
428040008
Device description
Isothermal Breathing Circuit Accessory
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
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Product Code Classifications

CodeDeviceSpecialtyClass
BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or NebulizerAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30889483583399PackageGS11000In Commercial Distribution
10889483583395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3088948358339930889483583399
1088948358339510889483583395

GMDN Terms

TermDefinition
Respiratory gas thermometerA non-sterile device intended to measure the temperature of respiratory gases prior to entering a patient’s airway to help manage patient comfort and facilitate therapeutic compliance. It is a slender, hollow glass tube with a bulb at the base that is filled with coloured alcohol whereby temperature is measured based on the capillary principle. It is intended to be inserted into a compatible temperature monitor port of a breathing circuit connecter (e.g., Y-piece connecter); it may be used in the home or healthcare facility. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods

Method

Contacts

PhoneEmail
(800)433-2797info@sun-med.com

Regulatory Flags

DUNS number
119058668
Device count
1
DM exempt
false
Premarket exempt
false
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
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

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30889483572126AirLife™Sunmed Group Holdings, LLCBZE2025-03-27
30889483573383AirLife™Sunmed Group Holdings, LLCBZE2025-03-27
30889483573802AirLife™Sunmed Group Holdings, LLCBZE2025-03-27
30889483605480AirLife™Sunmed Group Holdings, LLCBZE2025-03-27
10889483616932AirLife™Sunmed Group Holdings, LLCBZE2025-03-27
10889483616956AirLife™Sunmed Group Holdings, LLCBZE2025-03-27
0503026703366922MM FLEXTUBE DUAL HEATED WIRE BREATHING SYSTEM WITH EXTRA LIMBS.>1.6MIntersurgical IncorporatedBZE2025-03-14
0503026709791322MM FLEXTUBE DUAL H/W B/S WITH AUTO-FILL CHAMBER AND EXTRA LIMBS. >1.6MIntersurgical IncorporatedBZE2025-03-14
0503026703368322MM SMOOTHBORE SINGLE H/W BREATHING SYSTEM WITH WATER TRAP AND LIMB.>1.6MIntersurgical IncorporatedBZE2025-03-14
0503026709637422MM SMOOTHBORE SINGLE H/W B/S WITH WATER TRAP,AUTO-FILL CHAMBER,EXTRA LIMB>1.6MIntersurgical IncorporatedBZE2025-03-14
0503026703367622MM SMOOTHBORE DUAL H/W BREATHING SYSTEM WITH EXTRA LIMB. > 1.6MIntersurgical IncorporatedBZE2025-03-14
0503026716192822MM FLEXTUBE SINGLE H/W LIMB WITH AUTO-FILL CHAMBER AND EXTRA LIMB.>1.6MIntersurgical IncorporatedBZE2025-03-14
30889483584105AirLife™Sunmed Group Holdings, LLCBZE2025-03-07
30889483588356AirLife™Sunmed Group Holdings, LLCBZE2025-03-07
30889483595842AirLife™Sunmed Group Holdings, LLCBZE2025-03-07
30889483615618AirLife™Sunmed Group Holdings, LLCBZE2025-03-07
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30889483586529AirLife™Sunmed Group Holdings, LLCBZE2025-03-06
30889483587137AirLife™Sunmed Group Holdings, LLCBZE2025-03-06
30889483587328AirLife™Sunmed Group Holdings, LLCBZE2025-03-06
30889483591288AirLife™Sunmed Group Holdings, LLCBZE2025-03-06
30889483572652AirLife™Sunmed Group Holdings, LLCBZE2025-03-05
30889483572904AirLife™Sunmed Group Holdings, LLCBZE2025-02-27
10889483616994AirLife™Sunmed Group Holdings, LLCBZE2025-02-27
10889483617007AirLife™Sunmed Group Holdings, LLCBZE2025-02-27
30889483581043AirLife™Sunmed Group Holdings, LLCBZE2025-02-21
30889483581081AirLife™Sunmed Group Holdings, LLCBZE2025-02-21
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