FDA.report

Resp-O2 Durable Peak Flow Mouthpiece

Primary DI
00840117318359
Brand
Resp-O2 Durable Peak Flow Mouthpiece
Company
DYNAREX CORPORATION
Model
36116
Device description
Resp-O2 Durable Peak Flow Mouthpiece w/ One-Way valve; adult
Published
2021-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
BYPMouthpiece, Breathing

Product Code Classifications

CodeDeviceSpecialtyClass
BYPMouthpiece, BreathingAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840117318366PrimaryGS10
00840117318359Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117318366008401173183668401173183660840117318366
00840117318359008401173183598401173183590840117318359

GMDN Terms

TermDefinition
Breathing mouthpiece, reusableA device designed for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid hollow device with a shape and structure that enables an appropriate gastight seal and prevents collapse. The device accepts or attaches to, either directly or through other tubes/adapters, diagnostic/therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser). Some types generate a whistling sound to guide effective inhalation [e.g., during use of a metered dose inhaler (MDI)]. This is a reusable device which may be intended for single- or multi-patient use.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
true
Sterilization required before use
false

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