FDA.reportPublic FDA data

Prelude SNAP 165™

Primary DI
00884450484494
Brand
Prelude SNAP 165™
Company
Merit Medical Systems, Inc.
Model
10884450484491
Catalog number
PLS165/A
Published
2020-12-03
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
KGZACCESSORIES, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGZAccessories, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450484491PrimaryGS10
00884450484494Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445048449110884450484491
00884450484494008844504844948844504844940884450484494

GMDN Terms#

Term, Definition table
TermDefinition
Non-vascular catheter introduction setA collection of sterile, invasive devices intended to enable percutaneous Seldinger-type introduction of a non-vascular catheter (e.g., drainage catheter) into a body cavity or lumen (e.g., biliary tract, ureter); it is not intended for introduction of a peritoneal dialysis catheter. It includes multiple invasive access devices which typically include an introducer needle, introducer sheath with an inner dilator, and guidewire; the catheter is not included. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
Device count
10
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
true
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
00884450029756Merit Medical®Initial ReleaseK08-02280A2026-09-29
00884450421383Merit Medical®Initial ReleaseK09-09424A2026-09-29
00884450431917Merit Medical®Initial ReleaseK09-13874B2026-09-29
00884450436004Merit Medical®Initial ReleaseK12-05438A2026-09-29
00884450452974MAK-NV™DMAK-NV-0082026-09-29
00884450453339MAK-NV™DMAK-NV-0162026-09-29
00884450500002Merit Medical®Initial ReleaseK09-144152026-09-29
10884450119751Prelude EASE™JPHR6F11018SC2026-09-29
10884450280055Prelude®JPSI-4F-11-0182026-09-29
10884450415839Prelude®JPSI-7F-11-0182026-09-29
10884450439163Prelude IDeal™JPID6F11021SSC2026-09-29
10884450439187Prelude IDeal™JPID6F11021PW2026-09-29
10884450452353STAR™FRF-0510L-012026-09-29
10884450831547Tru-Cut®C2N2712X2026-09-29
00884450376867Merit Medical®Initial ReleaseK09-10502F2026-09-26
00884450431597Merit Medical®Initial ReleaseK09-12862A2026-09-26
00884450432105Merit Medical®Initial ReleaseK09-08926B2026-09-26
00884450707104Merit Medical®DTS1202026-09-26
00884450707111Merit Medical®DTS2202026-09-26
00884450028605Merit Medical®Initial ReleaseK08-01254A2026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06976712970341Hemo Luer LockMicro-Energy Medical Technology Co., LtdKGZ2026-07-13
H787TDST0AngioDynamicsAngiodynamics, Inc.KGZ2026-06-04
10198459435201MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGZ2025-07-21
10704411017882AMSure® Single Spike Infiltration TubingAMSINO INTERNATIONAL, INC.KGZ2025-06-23
10192253053609DevonCardinal Health 200, LLCKGZ2025-03-25
10192253042023DevonCardinal Health 200, LLCKGZ2025-03-07
10192253042030DevonCardinal Health 200, LLCKGZ2025-03-07
00840306835087Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2025-01-16
00840306835094Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2025-01-16
00840306835100Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2025-01-16
00840306835131Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2025-01-16
30382904275656BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-22
30382904275618BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
30382904275625BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
30382904275632BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
30382904275649BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
30382904275601BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-16
00815634021761FibrijetMicromedics, Inc.KGZ2024-06-18
00628725047638Safety Drain line adapterCanadian Hospital Specialties LimitedKGZ2024-06-17
10193489068245NAMICMEDLINE INDUSTRIES, INC.KGZ2023-12-21
10193489068108MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
10193489068115MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
10193489068122MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
10193489140187MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
10193489140194MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
M710WW12K0Wire Watch™BIOTEX, INC.KGZ2023-07-31
10850005416002MedDrainARMM INC.KGZ2023-06-08
10850005416019MedDrainARMM INC.KGZ2023-06-08
10850005416033MedDrainARMM INC.KGZ2023-06-08
10850005416071MedDrainARMM INC.KGZ2023-06-08