FDA.reportPublic FDA data

Adora Accessory

Primary DI
05713464000671
Brand
Adora Accessory
Company
Nrt - Nordisk Røntgen Teknik A/S
Model
04286500
Device description
IV Stand for the Adora DRFi X-ray system to be fixed in any position along the patient table to attach infusion bags during the examination.
Published
2025-09-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JAASystem, X-Ray, Fluoroscopic, Image-Intensified

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242948000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242948000Adora DRFi (04550010)Nrt X-Ray A/S2024-12-23JAA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713464000671PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713464000671057134640006715713464000671

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding/bed-attached intravenous poleA freestanding or equipment-attached metal rod with two or more hooked bars extending horizontally from its top from which various fluid delivery devices (bags or bottles) can be suspended for the administration of intravenous (IV) fluids/medication to the patient. It is used during infusion therapy for intravenous administration of fluids/solutions or blood transfusions. Infusion pumps and/or syringe pumps can also be attached to it. Also called an IV pole or drip pole, it can be a fixed or side-swinging, adjustable, vertical pole attached to a bed, operating table, wheelchair, or more commonly, an independent floor-standing IV pole for bedside use; some have wheels for patient mobility.

Contacts#

Phone, Email table
PhoneEmail
+4586283500nrt@nrtxray.com

Regulatory Flags#

DUNS number
307332705
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05713464000640Adora Accessory042822002025-09-16
05713464000657Adora Accessory042834002025-09-16
05713464000664Adora Accessory042863902025-09-16
05713464000688Adora Accessory042866002025-09-16
05713464000695Adora Accessory042895002025-09-16
05713464000701Adora Accessory042822402025-09-16
05713464000862Adora DRFi045500102025-09-16
05713464000329Intelli-C Accessory029199002019-01-21
05713464000435Intelli-C Accessory032856002019-05-01
05713464000442Intelli-C Accessory213200182019-05-01
05713464000459Intelli-C Accessory213300182019-05-01
05713464000756Intelli-C Accessory032849002022-05-31
05713464000343Intelli-C Accessory032845002019-01-21
05713464000732Intelli-C Accessory032820002022-04-11
05713464000749Intelli-C Accessory032830002022-04-11
05713464000336Intelli-C Accessory032820002019-01-21
05713464000381Intelli-C Accessory032830002019-02-19
05713464000411Intelli-C Accessory032840502021-04-16
05713464000565Intelli-C Accessory032842002021-04-16
05713464000374Intelli-C Accessory032826002020-10-20

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Primary DI, Brand, Company table
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00198953052488AlliaGE MEDICAL SYSTEMSJAA2025-12-17
08809244060618GenorayGENORAY CO., LTD.JAA2025-12-01
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08809244060700GenorayGENORAY CO., LTD.JAA2025-12-01
04056869993973LUMINOS Q.namix RSiemens Healthcare GmbHJAA2025-07-30
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08800018422601EXTRON 3DRTECH CorporationJAA2025-06-17
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00195278719720AlliaGE MEDICAL SYSTEMSJAA2023-12-08
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00195451000386Shockwave IVL System with the Shockwave L6 Peripheral IVL CatheterShockwave Medical, Inc.JAA2022-10-24
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