FDA.report

AirLife™

Primary DI
30889483631366
Brand
AirLife™
Company
Sunmed Group Holdings, LLC
Model
37736CE
Catalog number
37736CE
Device description
AirLife DuoTherm™ Pediatric Single Limb Circuit Kit
Published
2025-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
30889483631366PackageGS110In Commercial Distribution
10889483631362PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3088948363136630889483631366
1088948363136210889483631362

GMDN Terms

TermDefinition
Oxygen administration kitA collection of devices designed for oxygen (O2) delivery that may include a mask, a nasal cannula, oxygen tubing, disposable non-prefilled humidifier and connectors. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Special Storage Condition, Specify00Keep away from sunlight
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-433-2797info@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
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

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0503026704588422MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH LIMB.1.6MIntersurgical IncorporatedBZE2025-04-16
30889483572126AirLife™Sunmed Group Holdings, LLCBZE2025-03-27
30889483573383AirLife™Sunmed Group Holdings, LLCBZE2025-03-27
30889483573802AirLife™Sunmed Group Holdings, LLCBZE2025-03-27
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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
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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
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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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