FDA.reportPublic FDA data

n/a

Primary DI
00874750007059
Brand
n/a
Company
HANS RUDOLPH, INC.
Model
3500
Catalog number
112940
Device description
3500B PNT/HTRSHELL/CONN ASSY
Published
2016-09-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JAXPneumotachometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAXPneumotachometerAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00874750007059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00874750007059008747500070598747500070590874750007059

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
007131725
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

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008171360272657450 RV2 MASK74506123992023-04-05
008171360272967450 RV2 MASK74506127812023-04-05
008171360273337450 RV2 MASK74506128642023-04-05
008171360273957450 RV2 MASK7450CC17342023-04-05
008171360274017450 RV2 MASK7450CC17482023-04-05
008747500027957450 RV2 MASK74502015192023-04-05
008171360276927450 RV2 MASK74501138822024-07-15
008171360277087450 RV2 MASK74501138852024-07-15
008171360270127450 RV2 MASK74501136932022-11-08
008171360268177450 RV2 MASK74501138832022-03-10
008171360268247450 RV2 MASK74501138842022-03-10
008171360267947450 RV2 MASK74501138052022-02-22
008171360267567450 RV2 MASK74501138012021-10-04
008171360262067450 RV2 MASK74501138552019-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008171360265413830HANS RUDOLPH, INC.JAX2021-04-06
008171360263743830HANS RUDOLPH, INC.JAX2020-11-20
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008171360262208311 PNTHANS RUDOLPH, INC.JAX2019-07-18
00810016250814MGC DiagnosticsMEDICAL GRAPHICS CORPORATIONJAX2019-03-31
00810016250821MGC DiagnosticsMEDICAL GRAPHICS CORPORATIONJAX2019-03-31
00810016250838MGC DiagnsoticsMEDICAL GRAPHICS CORPORATIONJAX2019-02-22
008747500081319301 HAND CONTROLLERHANS RUDOLPH, INC.JAX2018-11-02
00817136025599n/aHANS RUDOLPH, INC.JAX2018-02-08
00817136025278n/aHANS RUDOLPH, INC.JAX2017-04-21
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B279298012F1FloSenseS D I DIAGNOSTICS INCJAX2017-02-11
B279298012K1FloSenseS D I DIAGNOSTICS INCJAX2017-02-11
B279298020F1FloSenseS D I DIAGNOSTICS INCJAX2017-02-11
B279298020K1FloSenseS D I DIAGNOSTICS INCJAX2017-02-11
B279298021F1FloSenseS D I DIAGNOSTICS INCJAX2017-02-11
B279298021K1FloSenseS D I DIAGNOSTICS INCJAX2017-02-11
00817136025063n/aHANS RUDOLPH, INC.JAX2016-10-17
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00874750006175n/aHANS RUDOLPH, INC.JAX2016-09-16
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00874750006243n/aHANS RUDOLPH, INC.JAX2016-09-16
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00874750006281N/AHANS RUDOLPH, INC.JAX2016-09-16