FDA.report

N/A

Primary DI
00874750006830
Brand
N/A
Company
HANS RUDOLPH, INC.
Model
8411
Catalog number
112830
Device description
8411A NON HTD PNT
Published
2016-09-16
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
false

Related Records

Product Codes

CodeName
JAXPneumotachometer

Product Code Classifications

CodeDeviceSpecialtyClass
JAXPneumotachometerAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00874750006830PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00874750006830008747500068308747500068300874750006830

GMDN Terms

TermDefinition
PneumotachographA device designed to graphically record the instantaneous flow (velocity) of air at the mouth or, using an integrated signal, the volume of air per breath during inspiration or expiration. This recorder consists of a resistance attachment (e.g., wire screen or capillary tubes) placed in a tube in which the respiratory gases flow, the pressure drop being linearly related to airflow velocity. It is used for displaying the dynamics of respiration, and also can be used, in conjunction with an oesophageal balloon, to measure static lung compliance or airway resistance in conjunction with a whole-body plethysmograph.

Sterilization Methods

Method

Regulatory Flags

DUNS number
007131725
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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