FDA.report

DeRoyal

Primary DI
50749756982004
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
79-401110
Catalog number
79-401110
Device description
RUSSELL 3 PORT MANIFOLD KIT
Published
2021-05-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DTLAdaptor, stopcock, manifold, fitting, cardiopulmonary bypass

Product Code Classifications

CodeDeviceSpecialtyClass
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50749756982004PackageGS120In Commercial Distribution
00749756982009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975698200450749756982004
00749756982009007497569820097497569820090749756982009

GMDN Terms

TermDefinition
Angiography kitA collection of sterile devices and equipment used to prepare a patient for the radiographic visualization of the arteries of a particular organ system or body part through the vascular injection of contrast media. It typically includes a combination of fluid/contrast media administration devices (e.g., tubing, manifold, stopcocks, and syringes) and/or dedicated angiography supportive devices (e.g., angiography drapes, covers, dressings); the angiography catheter is not included. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(888)938-7828udisupport@deroyal.com

Regulatory Flags

DUNS number
096372255
Device count
1
DM exempt
true
Premarket exempt
false
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
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
50749756033140DeRoyal10-513010-51302023-01-31
50749756392490DeRoyalNP-6006UNP-6006U2026-01-22
50749756397808DeRoyalNP-0080LMDNP-0080LMD2026-01-22
00749756401258DeRoyalSTM2000STM20002026-01-22
50749756401352DeRoyalM60-AP500M60-AP5002026-01-22
50749756401376DeRoyalM60-AP600M60-AP6002026-01-22
50749756401383DeRoyalM60-AP601M60-AP6012026-01-22
50749756401390DeRoyalM60-AP602M60-AP6022026-01-22
50749756401482DeRoyal46-LT19S-01B46-LT19S-01B2026-01-22
50749756401437DeRoyalM70-200PM70-200P2026-01-01
50749756401444DeRoyalM70-200CM70-200C2026-01-01
50749756401451DeRoyalM70-200CNWM70-200CNW2026-01-01
50749756401468DeRoyalM70-200PNWM70-200PNW2026-01-01
50749756394418DeRoyal71-080571-08052025-08-13
50749756396641DeRoyalPH81-010400PH81-0104002025-08-13
50749756397853DeRoyalPH81-020409PH81-0204092025-08-13
50749756397860DeRoyalPH81-020412PH81-0204122025-08-13
00749756399333DeRoyal1-524A-01-CHO1-524A-01-CHO2025-07-30
00749756399340DeRoyal1-524A-02-CHO1-524A-02-CHO2025-07-30
00749756399357DeRoyal1-524A-03-CHO1-524A-03-CHO2025-07-30

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10841268110073Hemostasis Valve AdapterGALT MEDICAL CORP.DTL2026-01-19
10884450312459TRAM®PMerit Medical Systems, Inc.DTL2025-12-23
20197344137487NAMICMEDLINE INDUSTRIES, INC.DTL2025-11-28
10884450662301AccessPLUS™Merit Medical Systems, Inc.DTL2025-09-03
40884389862101MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-08-12
40884389734569MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-08-05
10197344100187NAMICMEDLINE INDUSTRIES, INC.DTL2025-08-04
00194613123406MSI Precision Specialty InstrumentsMed Saver, Inc.DTL2025-08-01
40884389734217MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-07-31
40884389734385MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-07-31
40884389734897MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-07-31
40884389734910MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-07-31
40884389734927MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-07-31
40884389734934MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-07-31
40884389734941MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-07-31
40884389875651MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-07-31
40884389875682MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-07-31
40889942872801MEDLINEMEDLINE INDUSTRIES, INC.DTL2025-07-31
10884450859718CPS H. Lee SafeSheath® Sealing AdapterMerit Medical Systems, Inc.DTL2025-05-31
30193489068218NAMICMEDLINE INDUSTRIES, INC.DTL2025-05-15
10884450860936PhD™Merit Medical Systems, Inc.DTL2025-05-13
20884450860971Honor®Merit Medical Systems, Inc.DTL2025-05-13
10884450003982PhD™Merit Medical Systems, Inc.DTL2025-04-23
10884450664213Honor®Merit Medical Systems, Inc.DTL2025-04-18
10884450860097AccessPLUS™Merit Medical Systems, Inc.DTL2025-03-28
2088445082130910Fore™Merit Medical Systems, Inc.DTL2025-03-15
20884450818101MBA™Merit Medical Systems, Inc.DTL2025-02-22
1088445083250610Fore™Merit Medical Systems, Inc.DTL2025-02-22
20884450834170Passage®Merit Medical Systems, Inc.DTL2025-02-06
10884450834166Passage®Merit Medical Systems, Inc.DTL2025-01-31