FDA.reportPublic FDA data

UltraFlow™

Primary DI
10816843021440
Brand
UltraFlow™
Company
ROCHESTER ELECTRO-MEDICAL, INC.
Model
603775
Device description
DISPOSABLE ULTRAFLOW RESPIRATION MONITORS: LARGE, SINGLE CHANNEL (2 PLUGS, 1 CHANNEL), 1 ORAL & 2 NASAL RECORDING POINTS
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
10816843021440PrimaryGS10
10816843021457Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081684302144010816843021440
1081684302145710816843021457

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.

Contacts#

Phone, Email table
PhoneEmail
18003285544info@rochestermed.com

Regulatory Flags#

DUNS number
068156330
Device count
10
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10816843021235Rochester2220002016-09-24
10816843021259Rochester2221112016-09-24
10816843021273Rochester2224662016-09-24
10816843020009Rochester0322382016-09-24
10816843020023Rochester0325432016-09-24
10816843020047Rochester0356872016-09-24
10816843020061Rochester0356892016-09-24
10816843020085Rochester0383752016-09-24
10816843023741Rochester2220002016-09-24
10816843023765Rochester2221112016-09-24
10816843021297Rochester2224662016-09-24
10816843020276EverLast™BMS017T15-42016-09-24
10816843020290EverLast™BMS037T15-102016-09-24
10816843020313EverLast™BMS037T15-42016-09-24
10816843020337EverLast™BMS037T15-52016-09-24
10816843020351EverLast™BMS037T15-62016-09-24
10816843020375EverLast™BMS037T15-82016-09-24
10816843020399UltraLast™BMS042T15-42016-09-24
10816843020412UltraLast™BMS042T15-52016-09-24
10816843020436UltraLast™BMS042T15-62016-09-24

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