FDA.report

Regard™

Primary DI
20326053108406
Brand
Regard™
Company
RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
Model
HT0235
Published
2016-12-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
OESCardiac Catheterization Kit

Product Code Classifications

CodeDeviceSpecialtyClass
OESCardiac Catheterization KitCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20326053108406PackageGS12Not in Commercial Distribution
10326053108409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2032605310840620326053108406
1032605310840910326053108409

GMDN Terms

TermDefinition
Fluid/device delivery cardiac catheterA sterile, steerable, flexible tube containing electrodes intended to be introduced percutaneously into the heart chambers in order to provide a pathway for the controlled delivery and support of a selective infusion of fluids or transvenous devices to the heart (e.g., the coronary sinus) and coronary vasculature. It may also be used in the evaluation of cardiac arrhythmias from endocardial and intravascular sites. It is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite and have an actuator mechanism located at the proximal end used to steer the tip in the desired direction. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
945020902
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10326053120777Regard™CVRBTELSXL-REGCVRBTELSXL-REG2025-02-06
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20326053121528Regard™DBPCHILD-REG2024-12-02
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20326053121542Regard™DBPADLT-REG2024-12-02
20326053121559Regard™DBPADLTL-REG2024-12-02
20326053121566Regard™DBPLRGADLT-REG2024-12-02
20326053121573Regard™DBPLGADLTL-REG2024-12-02
20326053121580Regard™DBPTHIGH-REG2024-12-02

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