FDA.reportPublic FDA data

9301 HAND CONTROLLER

Primary DI
00874750008131
Brand
9301 HAND CONTROLLER
Company
HANS RUDOLPH, INC.
Model
9301
Catalog number
112177
Device description
PNEU HAND CNTRL SWITCH 9301
Published
2018-11-02
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
00874750008131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00874750008131008747500081318747500081310874750008131

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary function valveA non-sterile, dedicated valve intended to be used with a parent device for the measurement/analysis of a patient's pulmonary function. It is typically used to control inspired/expired gas directional flow and assist in the inhalation and distribution of test gases. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007131725
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008171360277395530 3L SYRINGE55301139752026-05-01
008171360277465530 3L SYRINGE55301139762026-05-01
008171360277227450 RV2 MASK7450CC16412025-10-16
008171360277157450 RV2 MASK74502018412025-09-19
008171360272417450 RV2 MASK74506122212023-04-05
008171360272587450 RV2 MASK74506122442023-04-05
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
00850008733048Accutach Flow SensorB&B Medical TechnologiesJAX2019-07-18
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
00817136025599n/aHANS RUDOLPH, INC.JAX2018-02-08
00817136025278n/aHANS RUDOLPH, INC.JAX2017-04-21
B279298010F1FloSenseS D I DIAGNOSTICS INCJAX2017-02-11
B279298010K1FloSenseS D I DIAGNOSTICS INCJAX2017-02-11
B279298011FFloSenseS D I DIAGNOSTICS INCJAX2017-02-11
B279298011KFloSenseS D I DIAGNOSTICS INCJAX2017-02-11
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
00874750006151n/aHANS RUDOLPH, INC.JAX2016-09-16
00874750006168n/aHANS RUDOLPH, INC.JAX2016-09-16
00874750006175n/aHANS RUDOLPH, INC.JAX2016-09-16
00874750006182N/AHANS RUDOLPH, INC.JAX2016-09-16
00874750006243n/aHANS RUDOLPH, INC.JAX2016-09-16
00874750006250n/aHANS RUDOLPH, INC.JAX2016-09-16
00874750006267n/aHANS RUDOLPH, INC.JAX2016-09-16
00874750006274N/AHANS RUDOLPH, INC.JAX2016-09-16
00874750006281N/AHANS RUDOLPH, INC.JAX2016-09-16
00874750006298N/AHANS RUDOLPH, INC.JAX2016-09-16