FDA.report

HUDSON RCI

Primary DI
44026704639746
Brand
HUDSON RCI
Company
TELEFLEX INCORPORATED
Model
IPN049761
Catalog number
1802
Device description
HUDSON RCI AsthmaMD Peak Flow Meter
Published
2019-02-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
BZHMETER, PEAK FLOW, SPIROMETRY

Product Code Classifications

CodeDeviceSpecialtyClass
BZHMeter, Peak Flow, SpirometryAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34026704639749PackageGS110In Commercial Distribution
44026704639746PackageGS16In Commercial Distribution
14026704639745PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3402670463974934026704639749
4402670463974644026704639746
1402670463974514026704639745

GMDN Terms

TermDefinition
Peak flow meter, manualA manual, hand-held instrument designed to measure only the maximum rate of expiratory gas flow [peak expiratory flow (PEF) or peak expiratory flow rate (PEFR)] from the lungs. It typically includes a tube for patient exhalation, an easy-to-grip handle, and a calibrated scale that shows the value of the peak flow. The device helps to discriminate the pulmonary status in routine tests performed in or outside of a clinical setting; it is also intended for periodic self-evaluation of the respiratory status of a patient, and to help in the treatment evaluation of patients suffering from chronic respiratory disorders (e.g., asthma, emphysema).

Device Sizes

TypeValueUnit
Height0.75Inch
Length5.75Inch
Width1.94Inch

Sterilization Methods

Method

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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