FDA.reportPublic FDA data

MADA MEDICAL PRODUCTS, INC.

Primary DI
00815160020399
Brand
MADA MEDICAL PRODUCTS, INC.
Company
MADA MEDICAL PRODUCTS, INC
Model
1534
Catalog number
1534
Device description
It is a demand valve with a hose without a mask. A non-sterile device that is used to regulate the therapeutic gas flow to a patient in response to the patient's breathing effort. It is used, e.g., in ventilator breathing circuits, resuscitation devices and in on demand analgesia devices. This is a reusable device.
Published
2018-08-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTLVentilator, Emergency, Powered (Resuscitator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTLVentilator, Emergency, Powered (Resuscitator)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K915564000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K915564000SPIROSLife Support Products, Inc.1992-01-30BTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815160020399PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815160020399008151600203998151600203990815160020399

GMDN Terms#

Term, Definition table
TermDefinition
Demand valveA non-sterile device that is used to regulate the therapeutic gas flow to a patient in response to the patient's breathing effort. It is used, e.g., in ventilator breathing circuits, resuscitation devices and in on demand analgesia devices. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
201-460-0454jeffadam@madamedical.com
201-460-0454dianelind@madamedical.com

Regulatory Flags#

DUNS number
048411862
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815160020573MADA MEDICAL PRODUCTS,INC.2772772018-08-20
00815160020597MADA MEDICAL PRODUCTS,INC.277-220V277-220V2018-08-20
00815160021310MADA MEDICAL PRODUCTS, INC.R1836GBHF-25GPR1836GBHF-25GP2024-04-22
00815160021129MADA MEDICAL PRODUCTS, INC.7000-MVP7000-MVP2023-06-27
00815160020498MADA MEDICAL PRODUCTS, INC.1301M1301M2023-09-02
00815160020504MADA MEDICAL PRODUCTS, INC.1301ME1301ME2023-09-02
00815160021280MADA MEDICAL PRODUCTS, INC.R1835-25GBHF-25R1835-25GBHF-252023-09-02
00815160021297MADA MEDICAL PRODUCTS, INC.1415MS1415MS2023-09-02
00815160021303MADA MEDICAL PRODUCTS, INC.1529E1529E2023-09-02
00815160021327MADA MEDICAL PRODUCTS, INC.1515A-151515A-152023-09-02
00815160021334MADA MEDICAL PRODUCTS, INC.1630-151630-152023-09-02
00815160021341MADA MEDICAL PRODUCTS, INC.1630-A151630-A152023-09-02
00815160021358MADA MEDICAL PRODUCTS, INC.1630A-15E1630A-15E2023-09-02
00815160021365MADA MEDICAL PRODUCTS, INC.163016302023-09-02
00815160021372MADA MEDICAL PRODUCTS, INC.1616-15E1616-15E2023-09-02
00815160021389MADA MEDICAL PRODUCTS, INC.1630M-15E1630M=15E2023-09-02
00815160021396MADA MEDICAL PRODUCTS, INC.1616-AE1616-AE2023-09-02
00815160021235MADA MEDICAL PRODUCTS, INC.1701-A1701-A2023-08-05
00815160021242MADA MEDICAL PRODUCTS, INC.1701-81701-82023-08-05
00815160021259MADA MEDICAL PRODUCTS, INC.135913592023-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10641043508473Neo-Tee T-Piece ResuscitatorMERCURY ENTERPRISES, INC.BTL2026-03-26
10887709145907PneupacICU MEDICAL, INC.BTL2025-12-04
10887709145914PneupacICU MEDICAL, INC.BTL2025-12-04
30887709145901PneupacICU MEDICAL, INC.BTL2025-12-04
30887709145918PneupacICU MEDICAL, INC.BTL2025-12-04
M68970110HMU020SAVe II+ Simplified Automated VentilatorSafeguard US Operating, LLCBTL2025-11-20
04048675686712VentStar Resus heated (N)Drägerwerk AG & Co. KGaABTL2025-05-14
04048675686736VentStar AutoBreath heated (N)Drägerwerk AG & Co. KGaABTL2025-05-14
04048675686729VentStar Resus heated (N)Drägerwerk AG & Co. KGaABTL2025-05-14
04048675686743VentStar AutoBreath heated (N)Drägerwerk AG & Co. KGaABTL2025-05-14
00850071887242Emergent RespiratoryMDL Solutions IncorporatedBTL2025-04-05
M6892500301010SAVeII+ Starter Bundle, 3-Patient – BasicSafeguard US Operating, LLCBTL2025-02-26
M6892501001010SAVeII+ Starter Bundle, 10-Patient – BasicSafeguard US Operating, LLCBTL2025-02-26
00637320061239VORTRAN GO2VENT® with Peep ValveVORTRAN MEDICAL TECHNOLOGY 1, INCBTL2025-02-20
M68970111HUS010SAVe II+ Simplified Automated VentilatorSafeguard US Operating, LLCBTL2024-12-17
10641043913161Neo-Tee T-Piece Resuscitator CircuitMERCURY ENTERPRISES, INC.BTL2024-02-08
10641043913352Neo-Tee T-Piece Resuscitator CircuitMERCURY ENTERPRISES, INC.BTL2024-02-08
10641043913659Neo-Tee T-Piece Resuscitator CircuitMERCURY ENTERPRISES, INC.BTL2024-02-08
30641043913165Neo-Tee T-Piece Resuscitator CircuitMERCURY ENTERPRISES, INC.BTL2024-02-08
30641043913356Neo-Tee T-Piece Resuscitator CircuitMERCURY ENTERPRISES, INC.BTL2024-02-08
30641043913653Neo-Tee T-Piece Resuscitator CircuitMERCURY ENTERPRISES, INC.BTL2024-02-08
00851629008072SAVe II+Automedx, LLCBTL2024-01-06
10851629008079SAVe II+Automedx, LLCBTL2024-01-06
20851629008076SAVe II+Automedx, LLCBTL2024-01-06
90851629008075SAVe II+Automedx, LLCBTL2024-01-06
07898671250175OXYMAGMAGNAMED TECNOLOGIA MEDICA SABTL2023-12-06
10889483231739VentlabVENTLAB, LLCBTL2023-07-18
10889483231746VentlabVENTLAB, LLCBTL2023-07-18
10889483231760VentlabVENTLAB, LLCBTL2023-07-18
10889483231777VentlabVENTLAB, LLCBTL2023-07-18