FDA.reportPublic FDA data

Monsoon III

Primary DI
07640140861395
Brand
Monsoon III
Company
Acutronic Medical Systems AG
Model
7700.US
Catalog number
7700.US
Device description
+ Universal Jet Ventilator USA
Published
2023-01-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
CBKVentilator, Continuous, Facility Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)Anesthesiology2
CBKVentilator, Continuous, Facility UseAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640140861395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640140861395076401408613957640140861395

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(833)327-3284customersupport@vyaire.com

Regulatory Flags#

DUNS number
481327922
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640140860749Monsoon III Laserjet 702551052023-01-20
07640140860862Monsoon III Laserjet 402531052023-01-20
07640140861616MONSOON+7700.US7700.US2016-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00814747025246Novaplus Full Face AAV Non Vented Mask, LargeSLEEPNET, CORP.CBK2026-10-23
00814747025253Novaplus Full Face AAV Non Vented Mask, MediumSLEEPNET, CORP.CBK2026-10-23
00814747025260Novaplus Full Face AAV Non Vented Mask, SmallSLEEPNET, CORP.CBK2026-10-23
00814747025277Novaplus Full Face Non Vented Mask, Extra LargeSLEEPNET, CORP.CBK2026-10-23
00814747025284Novaplus Full Face Non Vented Mask, LargeSLEEPNET, CORP.CBK2026-10-23
00814747025291Novaplus Full Face Non Vented Mask, MediumSLEEPNET, CORP.CBK2026-10-23
00814747025307Novaplus Full Face Non Vented Mask, SmallSLEEPNET, CORP.CBK2026-10-23
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00850018561716NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561723NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561730NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561785NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561792NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561808NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561815NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561822NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561839NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561846NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561853NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561860NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
10197344010813HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-09-21
00198843006454LTVZoll Medical CorporationCBK2026-09-18
00198843006492LTVZoll Medical CorporationCBK2026-09-18
00198843006515LTVZoll Medical CorporationCBK2026-09-18
00198843006539LTVZoll Medical CorporationCBK2026-09-18
00198843007352LTVZoll Medical CorporationCBK2026-09-18
10197344016884HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016891HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016938HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27