FDA.report

Regard™

Primary DI
20326053106976
Brand
Regard™
Company
RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
Model
CV0364
Published
2016-12-05
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
OEQAngiography/Angioplasty Kit

Product Code Classifications

CodeDeviceSpecialtyClass
OEQAngiography/Angioplasty KitCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20326053106976PackageGS13Not in Commercial Distribution
10326053106979PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2032605310697620326053106976
1032605310697910326053106979

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

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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10326053117692Regard™A3PMSKUL4-REG2021-04-09
10326053117845Regard™A3SRGMSK2-REG2021-04-09
10326053117937Regard™VNYLEXMS3-REGVNYLEXMS3-REG2023-01-11
10326053117944Regard™VNYLEXMM3-REGVNYLEXMM3-REG2023-01-11
10326053117951Regard™VNYLEXML3-REGVNYLEXML3-REG2023-01-11
10326053117968Regard™VNYLEXMXL3-REGVNYLEXMXL3-REG2023-01-11
10326053117999Regard™A3SRGST4X-REG74713002021-04-20
20326053123164Regard™PVP1KIT- REG2025-08-15
10326053118026Regard™361066REG2025-06-10
10326053120777Regard™CVRBTELSXL-REGCVRBTELSXL-REG2025-02-06
10326053120784Regard™CVRBTTIEXL-REGCVRBTTIEXL-REG2025-01-28
20326053121528Regard™DBPCHILD-REG2024-12-02
20326053121535Regard™DBPSMADLT-REG2024-12-02
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

Other Devices Sharing Product Codes

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50198956325331CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956332872CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956337969CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956339918CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956341508CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
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50198956346541CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956353211CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956353488CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956359466CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956364057CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956365399CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956373110CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956400892CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956409703CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956411997CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956412154CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956413526CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956414707CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956415360CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956415483CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956416305CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956417937CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23