FDA.report

MULTIFLOW

Primary DI
00849593015585
Brand
MULTIFLOW
Company
AMC
Model
SM-602353
Device description
DUAL NO CASING RESP. MONITOR
Published
2019-05-03
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
false

Related Records

Contact Domains

Product Codes

CodeName
BZQMonitor, Breathing Frequency

Product Code Classifications

CodeDeviceSpecialtyClass
BZQMonitor, Breathing FrequencyAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00849593015585PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00849593015585008495930155858495930155850849593015585

GMDN Terms

TermDefinition
Patient monitoring system module, electrocardiographic/respiratoryA small unit dedicated to the measurement of the electrical activity of the heart in the form of an electrocardiogram (ECG) and to follow patient respiration patterns to identify episodes of arrhythmia and/or apnoea also derived from the ECG. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the electrocardiographic/respiratory information.

Sterilization Methods

Method

Contacts

PhoneEmail
954-345-9800info@advantagemed.com

Regulatory Flags

DUNS number
080242300
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00849593025133GoldSelect™DE-0037602023-01-30
20849593005344LifeSyncLS-238B2022-11-21
00084959302521GoldSelect™DGE-602022-11-18
00849593005746LifeSyncLS-2282022-11-20
20849593005764LifeSyncLS-2292022-11-20
00849593005784LifeSyncLS-228D2022-11-20
20849593005801LifeSyncLS-229D2022-11-20
00849593025140GoldSelect™DE-0037602022-11-20
00849593025157GoldSelect™DE-0037102022-11-20
00849593025164GoldSelect™DE-003748-252022-11-20
00849593025171GoldSelect™DE-003760-252022-11-20
00849593025188GoldSelect™DE-003772-252022-11-20
00849593025195GoldSelect™DE-003748-VA2022-11-18
00849593025201GoldSelect™DGE-482022-11-18
00849593025225GoldSelect™DGE-722022-11-18
00849593025232GoldSelect™DGE-1202022-11-18
00849593025249GoldSelect™DE-0037482022-11-18
00849593004138AMCCB-73331R2022-10-17
00849593031998AMCLW-3090024/5A2022-10-17
00849593025041LifeSyncAB 1000 (S)CB-AB 1000-0 (S)2022-10-03

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
20653405024948CONMEDConmed CorporationBZQ2026-03-24
20653405048142CONMEDConmed CorporationBZQ2026-03-24
20889483224363MVAP Comfort Sleep Nasal CannulaSALTER LABSBZQ2026-03-13
20889483225292MVAP Comfort Sleep Nasal CannulaSALTER LABSBZQ2026-03-13
B1400580A1BRAEBON PT1 Low Gain/ Hi Pressure Transducer Kit for AliceBraebon Medical CorporationBZQ2026-03-06
B1400580D1BRAEBON PT2 Dual Differntial Airflow Pressure KitBraebon Medical CorporationBZQ2026-03-06
B1400580N1BRAEBON Ultima Airflow Pressure KitBraebon Medical CorporationBZQ2026-03-06
B1400580PES1BRAEBON Ultima Esophageal Pressure TransducerBraebon Medical CorporationBZQ2026-03-06
00195278990914Portrait CSSXBGe Medical Systems Information Technologies, Inc.BZQ2025-12-10
00198953030981PORTRAIT HSWXBGE Healthcare Finland OyBZQ2025-12-10
08809988780049Xandar Kardian Vital Sign Monitoring Sensor (Model: XK300-E)Xandar Kardian Korea Inc.BZQ2025-12-04
06944413838437Patient MonitorEdan Instruments, Inc.BZQ2025-09-05
06944413838444Patient MonitorEdan Instruments, Inc.BZQ2025-09-05
30889483610569Resmed Sleep Apnealink CannulaSALTER LABSBZQ2025-07-11
B14003760BRAEBON Interface Cable for Alice 6Braebon Medical CorporationBZQ2025-04-30
B1400580AXA0BRAEBON PT1 Low Gain/ Hi Pressure Transducer Kit for AliceBraebon Medical CorporationBZQ2025-04-30
00860004541745ANNE ChestSibel Health Inc.BZQ2025-04-02
00860006382308SENSINEL™ CPM REPLACEMENT ADHESIVE PADAnalog Devices, Inc.BZQ2025-03-13
00843997006187Radius VSMMASIMO CORPORATIONBZQ2024-08-19
06944413815902Patient MonitorEdan Instruments, Inc.BZQ2024-06-17
07649996477019Sleepiz One+Sleepiz AGBZQ2024-05-14
B1400514A0BRAEBON cTherm Cannula Thermistor for Alice PDXBraebon Medical CorporationBZQ2024-03-25
B1400572A0BRAEBON Q-RIP Belt for AliceBraebon Medical CorporationBZQ2024-03-25
B1400572AL0BRAEBON Q-RIP Belt for Alice, LargeBraebon Medical CorporationBZQ2024-03-25
B1400572APED0BRAEBON Q-RIP Belt, PediatricBraebon Medical CorporationBZQ2024-03-25
B1400573A0Q-RIP to Belt Controller Cable for AliceBraebon Medical CorporationBZQ2024-03-25
B1408592A0Q-RIP to Belt Controller Cable for AliceBraebon Medical CorporationBZQ2024-03-25
00851540007161ExSpiron Pediatric PadSetsSenzime AB (Publ.)BZQ2024-01-25
08809988780001Xandar Kardian Vital Sign Monitoring Sensor (Model: XK300)Xandar Kardian Korea Inc.BZQ2024-01-19
B1400585PESXA0BRAEBON Ultima Esophageal Pressure TransducerBraebon Medical CorporationBZQ2024-01-05