FDA.reportPublic FDA data

N/A

Primary DI
04052536184088
Brand
N/A
Company
Ulrich GmbH & Co. KG
Model
XD 40101
Catalog number
XD 40101
Device description
ulrich Transfer Set, 20 in for USA only: For use with Omnipaque Imaging Bulk Package
Published
2017-07-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PQHIodinated contrast media transfer tubing set

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PQHIodinated Contrast Media Transfer Tubing SetGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161723000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161723000ulrich Transfer SetUlrich GmbH & Co. KG2016-12-21PQH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04052536184088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04052536184088040525361840884052536184088

GMDN Terms#

Term, Definition table
TermDefinition
Fluid transfer set, general-purposeA collection of sterile devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4907319654152safety@ulrichmedical.com

Regulatory Flags#

DUNS number
315494757
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04052536078349neon3CS 71502026-06-09
04052536078356neon3CS 71522026-06-09
04052536078363neon3CS 71542026-06-09
04052536123728mamboCS 71342026-06-09
04052536163403neon3CS 3994-002-0002026-06-09
04052536163410neon3CS 3994-001-0002026-06-09
04052536163434neon3CS 3994-003-0002026-06-09
04052536164585neon3CS 3994-001-0012026-06-09
04052536164592neon3CS 3994-001-0022026-06-09
04052536164608neon3CS 3994-001-0032026-06-09
04052536169931neon3CS 71552026-06-09
04052536177516neon3CS 7040-652026-06-09
04052536218073uCentumUL 8526-232026-06-09
04052536218080uCentumUL 8527-232026-06-09
04052536221202uCentumCS 7020-62026-06-09
04052536221219uCentumCS 7040-42026-06-09
04052536221233uCentumCS 7040-62026-06-09
04052536085651neon3CS 39412026-06-08
04052536085668neon3CS 39422026-06-08
04052536161997neon3CS 3940-012026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00616258022369MEDRAD Imaging Bulk Package Transfer SpikeBayer Medical Care Inc.PQH2024-04-15
40616258022367MEDRAD Imaging Bulk Package Transfer SpikeBayer Medical Care Inc.PQH2024-04-15
00616258008196MEDRAD® Imaging Bulk Package Transfer SetBAYER MEDICAL CARE INC.PQH2018-08-03
40616258008194MEDRAD® Imaging Bulk Package Transfer SetBAYER MEDICAL CARE INC.PQH2018-08-03