FDA.reportPublic FDA data

MONSOON+

Primary DI
07640140861616
Brand
MONSOON+
Company
Acutronic Medical Systems AG
Model
7700.US
Catalog number
7700.US
Device description
High frequency ventilator
Published
2016-10-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBKVENTILATOR, CONTINUOUS, FACILITY USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBKVentilator, Continuous, Facility UseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012691000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012691000MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIESAcutronic Medical Systems AG2002-12-20CBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640140861616PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640140861616076401408616167640140861616

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41447297080regulatory@acutronic-medical.ch

Regulatory Flags#

DUNS number
481327922
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
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
07640140861395Monsoon III7700.US7700.US2023-01-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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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