FDA.reportPublic FDA data

Ultiri™

Primary DI
05415067037626
Brand
Ultiri™
Company
LIGHTLAB IMAGING, INC.
Model
1015082
Catalog number
1015082
Device description
Measurement System
Published
2022-08-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSKCOMPUTER, BLOOD-PRESSURE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSKComputer, Blood-PressureCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067037626PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067037626054150670376265415067037626

GMDN Terms#

Term, Definition table
TermDefinition
Coronary optical coherence tomography systemAn assembly of optical and computer-based devices that use a broad-bandwidth light beam for optical coherence tomography (OCT) to provide high-resolution images (e.g., 5 to 40 microns) of the coronary intravasculature. It typically consists of a main operator's console which includes a computer for image storage, keyboard/mouse controls, and a visual display unit (VDU); audio recording facilities; and a printer. The system includes an optical-imaging catheter which is connected to the console for transmission of the images from the intravascular site. The system may be used during interventional cardiology, radiology, or diagnostic angiography.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature in a dry place. Excursions permitted between -20–50°C (-4–122°F), 25–90% relative humidity

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
018493531
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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05415067053879ILUMIEN™ OPTIS™ to OPTIS™UIMG901003UIMG9010032025-07-31
05415067047694Ultreon™101531010153102024-03-29
05415067025715PressureWire™C12059C120592016-08-19
05415067025739PressureWire™C12009C120092016-08-19
05415067025722PressureWire™C12359C123592016-08-19
05415067048882AptiVue™101520910152092023-09-29
00183739000647Dragonfly™ OPTIS™C408645C4086452015-04-20
00183739000654Dragonfly™ OPTIS™C408646C4086462015-04-20
05415067031129Dragonfly OpStar™101465110146512019-12-17
00183739000678ILUMIEN™C408650C4086502016-03-23
00812059020126OPTIS™C408653C4086532015-09-28
05415067030856AptiVue™101466610146662020-10-26
00183739000937OPTIS™Integrated SystemC4086522015-09-28
00812059021420OPTIS™Mobile SystemC4086612015-12-21
00183739000562C7 Dragonfly™100-100-00100-100-002015-04-17
00183739000623Dragonfly™Kit100-100-KT2015-04-20
00183739000630ILUMIEN™900-700-00900-700-002016-03-23
00183739000692Dragonfly™Duo KitC4086432015-04-20
00183739000708Dragonfly™DuoC4086442015-04-20

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