FDA.reportPublic FDA data

9300

Primary DI
00817136020037
Brand
9300
Company
HANS RUDOLPH, INC.
Model
9300
Catalog number
112783
Device description
9314 SUB/MATES 1410/9301 HCNTL
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
BYXTubing, Pressure And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817136020037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817136020037008171360200378171360200370817136020037

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
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
00628101548254OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101559618OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101595708OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101599980OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101622374OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631543OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631567OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631574OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631628OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631635OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631642OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631673OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631680OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631703OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631710OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631727OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631734OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631741OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631758OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631802OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631819OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631826OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631833OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631871OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631888OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631918OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631925OhioOHIO MEDICAL, LLCBYX2026-03-23
00628101631932OhioOHIO MEDICAL, LLCBYX2026-03-23
00628101631949OhioOHIO MEDICAL, LLCBYX2026-03-23
00848530108632CPAP TubingSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-03-19