FDA.reportPublic FDA data

MULTIFLOW

Primary DI
00849593015608
Brand
MULTIFLOW
Company
AMC
Model
SM-602548
Device description
NO CASING MULTIFLOW RESPIRATION MONITOR: SINGLE THERMOCOUPLE, SINGLE CHANNEL (2 PLUGS, 1 CHANNEL)
Published
2019-01-02
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZQMonitor, Breathing Frequency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZQMonitor, Breathing FrequencyAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849593015608PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849593015608008495930156088495930156080849593015608

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
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 DI, Brand, Model table
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

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