FDA.reportPublic FDA data

AccessPLUS™

Primary DI
10884450590352
Brand
AccessPLUS™
Company
Merit Medical Systems, Inc.
Model
00884450590355
Catalog number
MAP151/D
Published
2022-05-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DTLAdaptor, stopcock, manifold, fitting, cardiopulmonary bypass
OEQAngiography/angioplasty kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassCardiovascular2
OEQAngiography/Angioplasty KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450590352PackageGS125In Commercial Distribution
20884450590359PackageGS14In Commercial Distribution
00884450590355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445059035210884450590352
2088445059035920884450590359
00884450590355008844505903558844505903550884450590355

GMDN Terms#

Term, Definition table
TermDefinition
Haemostasis valveA noninvasive device designed as a conduit through which a small-diameter diagnostic/interventional device(s) can be introduced into or withdrawn from a patient's vasculature while preventing backflow of blood; it might in addition be intended for urinary applications. It is intended to be attached, typically via Luer-lock, to an invasively-placed catheter introducer (not included) and typically has a self-sealing lumen(s) [e.g., Touhy-Borst valve] and sideport for the introduction of solutions. It may include noninvasive guidewire accessories (e.g., guidewire introducer). It is not designed to be connected between tubing (i.e., not an in-line valve). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450423790Merit Medical®Initial ReleaseK09-10667B2026-07-03
00884450438480Merit Medical®Initial ReleaseK10-03045C2026-07-03
00884450486337Merit Medical®Initial ReleaseK10T-062082026-07-03
00884450079973Merit Medical®Initial ReleaseK09-10089M2026-06-09
00884450101537Merit Medical®Initial ReleaseK09-143202026-06-09
00884450101568Merit Medical®Initial ReleaseK09-143212026-06-09
00884450435748SCOUT®MSG-012026-06-09
00884450486962Merit Medical®Initial ReleaseK09-144042026-06-09
00884450486993Merit Medical®Initial ReleaseK10-062032026-06-09
00884450767542SCOUT MD™BSSCMD-012026-06-09
00884450826560Fountain®BIS5-135-302026-06-09
10884450114008Prelude IDeal™HPID4F11018SS2026-06-09
10884450119799Prelude EASE™JPHR6F11021PW2026-06-09
00884450467572DuraMax®CH7871030281952026-06-08
00884450469033BioFlo DuraMax®BH9651030281612026-06-08
00884450469132BioFlo DuraMax®BH9651030282112026-06-08
00884450787663Impress®C44038STS2026-06-08
10884450114855Prelude IDeal™HPID5F16021PW2026-06-08
00884450030592Merit Medical®Initial ReleaseK08-02650A2026-06-06
00884450107072Merit Medical®Initial ReleaseK09-13880A2026-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956373655CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-06
10198956416482CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-06
10198956514119CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-06
10198956515789CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-06
10198956516083CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-06
10198956517844CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-06
10198956518025CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-06
10198956520301CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-06
10198956526464CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-06
10198956526808CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-06
10198956527065CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-06
10198956527911CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-06
10198956394261CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956406605CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956428300CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956452589CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956466395CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956469099CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956481947CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956483095CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956487284CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956494718CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956495586CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956496118CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956496231CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956496521CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956496637CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956496682CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956496811CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08
10198956498716CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-06-08