FDA.report

Prelude EASE™

Primary DI
20884450289239
Brand
Prelude EASE™
Company
Merit Medical Systems, Inc.
Model
10884450289232
Catalog number
PHR5F23021PW/C
Published
2017-02-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
DYBINTRODUCER, CATHETER

Product Code Classifications

CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20884450289239PackageGS14In Commercial Distribution
10884450289232PrimaryGS10
00884450289235Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2088445028923920884450289239
1088445028923210884450289232
00884450289235008844502892358844502892350884450289235

GMDN Terms

TermDefinition
Vascular dilator, single-useA sterile, hand-held, surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method

Regulatory Flags

DUNS number
184763290
Device count
5
DM exempt
false
Premarket exempt
false
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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10884450112721Merit Medical®Initial ReleaseK09-10994G2026-03-21
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10884450428532Merit Medical®Initial ReleaseK09-09762A2026-03-21
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10884450440602Merit Medical®Initial ReleaseK09-11433M2026-03-21
20884450441514Merit Medical®Initial ReleaseK09-14148B2026-03-21
20884450441552Merit Medical®Initial ReleaseK12-12053B2026-03-21
10884450441784SteadySheath®BLR-TSS-13.02026-03-21

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Primary DIBrandCompanyProduct codePublished
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20886333227871V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227888V-Stick Vascular Access Set ARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227895V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227901V-Stick Vascular Access Set ARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227918V- Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227925V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227932V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
00813502010411Impella RP Flex Introducer KitAbiomed, Inc.DYB2026-03-11
00813502011685Abiomed Impella CP 14Fr Introducer KitAbiomed, Inc.DYB2026-03-11
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20801902225508ARROWTELEFLEX INCORPORATEDDYB2026-03-11
20801902225546ARROWTELEFLEX INCORPORATEDDYB2026-03-11
00840479401263enableCV Introducer SheathENABLECV INC.DYB2026-02-26
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50382903829472Insyte AutoguardBECTON, DICKINSON AND COMPANYDYB2026-02-13
50382903829540Insyte AutoguardBECTON, DICKINSON AND COMPANYDYB2026-02-13
20801902225133ARROWTELEFLEX INCORPORATEDDYB2026-02-13
20801902225171ARROWTELEFLEX INCORPORATEDDYB2026-02-13
00884450465981HeartSpan®Merit Medical Systems, Inc.DYB2026-02-07