FDA.reportPublic FDA data

WRAPSODY®

Primary DI
00884450845790
Brand
WRAPSODY®
Company
Merit Medical Systems, Inc.
Model
A
Catalog number
WRAP-S06050
Published
2025-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PFVSystem, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PFVSystem, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis TreatmentUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884450845790PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450845790008844508457908844508457900884450845790

GMDN Terms#

Term, Definition table
TermDefinition
Central/peripheral venous endovascular stent-graftA non-bioabsorbable tubular device designed to be implanted in a central and/or peripheral vein (e.g., subclavian, brachiocephalic) to maintain vessel lumen patency, typically to treat stenosis in the outflow of an arteriovenous fistula (AVF) or graft used for haemodialysis; it is not intended for coronary or intracranial venous stenting. It is a mesh structure made of metal [e.g., nickel-titanium alloy] that is covered with a synthetic polymer [e.g., polytetrafluoroethylene (ePTFE)] membrane (endovascular graft), and contains an inner carbon coating to help prevent platelet adhesion. It is typically expanded in situ and disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450433812Merit Medical®Initial ReleaseK08-02803A2026-07-23
00884450485163Merit Medical®Initial ReleaseK12T-11888B2026-07-23
00884450376546Merit Medical®Initial ReleaseK09-05229L2026-07-22
00884450431764Merit Medical®Initial ReleaseK10-04836A2026-07-22
00884450488751Merit Medical®Initial ReleaseK09-144102026-07-22
00884450492888Merit Medical®Initial ReleaseK01-08008A2026-07-22
00884450499276Merit Medical®Initial ReleaseK09-13679B2026-07-22
00884450421581Merit Medical®Initial ReleaseK12-08733A2026-07-21
00884450795705Merit Medical®Initial ReleaseK12-10248A2026-07-21
00884450457382C2 CryoBalloon™AFG-10132026-07-20
00884450163344Merit Medical®Initial ReleaseK09-11661B2026-07-18
00884450486627Merit Medical®Initial ReleaseK12T-09218A2026-07-18
00884450486641Merit Medical®Initial ReleaseK12T-127262026-07-17
00884450486849Merit Medical®Initial ReleaseK12T-127272026-07-17
10884450708955Prelude®FPSI-8F-11-035-18G2026-07-18
00884450014523ReSolve®, StayFIX®,ARLCMB-NV-10-SFX2026-07-16
00884450161777Merit Medical®Initial ReleaseK09-10897B2026-07-16
00884450432075Merit Medical®Initial ReleaseK11-01125B2026-07-16
00884450434482Merit Medical®Initial ReleaseK10-05031A2026-07-14
00884450493182Merit Medical®Initial ReleaseK09-09809C2026-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450845820WRAPSODY®Merit Medical Systems, Inc.PFV2026-06-24
00884450845400WRAPSODY®Merit Medical Systems, Inc.PFV2026-05-05
00884450845561WRAPSODY®Merit Medical Systems, Inc.PFV2026-04-21
00884450845387WRAPSODY®Merit Medical Systems, Inc.PFV2026-02-14
00884450845851WRAPSODY®Merit Medical Systems, Inc.PFV2025-12-16
00884450845813WRAPSODY®Merit Medical Systems, Inc.PFV2025-10-07
00884450845608WRAPSODY®Merit Medical Systems, Inc.PFV2025-08-08
00884450845806WRAPSODY®Merit Medical Systems, Inc.PFV2025-07-01
00884450845844WRAPSODY®Merit Medical Systems, Inc.PFV2025-06-18
00884450845615WRAPSODY®Merit Medical Systems, Inc.PFV2025-05-24
00884450845905WRAPSODY®Merit Medical Systems, Inc.PFV2025-05-24
00884450845417WRAPSODY®Merit Medical Systems, Inc.PFV2025-05-15
00884450845394WRAPSODY®Merit Medical Systems, Inc.PFV2025-05-14
00884450845653WRAPSODY®Merit Medical Systems, Inc.PFV2025-05-13
00884450845691WRAPSODY®Merit Medical Systems, Inc.PFV2025-05-13
00884450845714WRAPSODY®Merit Medical Systems, Inc.PFV2025-05-13
00884450845639WRAPSODY®Merit Medical Systems, Inc.PFV2025-04-21
00884450845660WRAPSODY®Merit Medical Systems, Inc.PFV2025-04-18
00884450845462WRAPSODY®Merit Medical Systems, Inc.PFV2025-03-22
00884450845622WRAPSODY®Merit Medical Systems, Inc.PFV2025-03-22
00884450845684WRAPSODY®Merit Medical Systems, Inc.PFV2025-03-15
00884450845950WRAPSODY®Merit Medical Systems, Inc.PFV2025-03-08
00884450845967WRAPSODY®Merit Medical Systems, Inc.PFV2025-03-08
00884450845646WRAPSODY®Merit Medical Systems, Inc.PFV2025-03-04
00884450845738WRAPSODY®Merit Medical Systems, Inc.PFV2025-02-21
00884450845516WRAPSODY®Merit Medical Systems, Inc.PFV2025-02-12
00884450845677WRAPSODY®Merit Medical Systems, Inc.PFV2025-02-12
00884450845776WRAPSODY®Merit Medical Systems, Inc.PFV2025-02-06
00884450845899WRAPSODY®Merit Medical Systems, Inc.PFV2025-01-30
00884450845752WRAPSODY®Merit Medical Systems, Inc.PFV2025-01-29