FDA.reportPublic FDA data

Merit Medical®

Primary DI
10884450021368
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450021361
Catalog number
DCVP1500
Published
2016-09-24
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

Product Codes#

Code, Name table
CodeName
DYBINTRODUCER, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040150000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040150000MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCERMedamicus, Inc.2004-02-18DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450021368PackageGS15In Commercial Distribution
20884450021365PackageGS14In Commercial Distribution
00884450021361PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445002136810884450021368
2088445002136520884450021365
00884450021361008844500213618844500213610884450021361

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia conduction catheter holder, sterileA sterile device in the form of an adhesive backed pad with a locking mechanism that is used to secure an anaesthesia conduction catheter at the skin insertion site to prevent catheter migration. Also known as an epidural securement device. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450431252Merit Medical®Initial ReleaseK09-11873C2026-09-04
00884450431979Merit Medical®Initial ReleaseK09-14157A2026-09-04
00884450456217Merit Medical®ALR-SGH0012026-09-04
00884450456224Merit Medical®ALR-CEX0012026-09-04
00884450456231Merit Medical®ALR-PVP0012026-09-04
00884450501696Merit Medical®Initial ReleaseK12T-12741A2026-09-04
10884450457549C2 CryoBalloon™AFG-10502026-09-05
00884450430118Merit Medical®Initial ReleaseK12-05157A2026-08-27
00884450440544Merit ®ALR-STS0012026-08-27
00884450450970Merit Medical®ALR-CLP0022026-08-27
00884450466995Needle's Eye Snare®ALR-NES0022026-08-27
00884450685785SCOUT®TSSR05-012026-08-27
00884450685792SCOUT®TSSR10-012026-08-27
00884450685808SCOUT®TSSR75-012026-08-27
00884450685822SCOUT MD™BSGMD-012026-07-01
00884450685839SCOUT MD™BSGMD-022026-07-01
00884450840597Prelude Roadster™APG4F90S2026-08-27
10884450119836Prelude EASE™JPHR6F11025PW2026-08-27
00884450435748SCOUT®MSG-012026-06-09
00884450767542SCOUT MD™BSSCMD-012026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450840597Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-27
06974949030920CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
06974949030944CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
10801902227246ARROWTELEFLEX INCORPORATEDDYB2026-08-27
10884450119836Prelude EASE™Merit Medical Systems, Inc.DYB2026-08-27
00884450838211Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-18
00199874352930Transseptal Puncture DevicePROTARYX MEDICAL INC.DYB2026-07-15
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATINGFREUDENBERG MEDICAL, LLCDYB2026-01-29
00850291007260Intri24 Introducer SheathInari Medical, Inc.DYB2023-03-20
10801902190519ARROWTELEFLEX INCORPORATEDDYB2021-09-02
04251244500641DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500719DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500801DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500818DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500832DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500849DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500856DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244501099DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244501075DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244501082DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500795DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2020-11-04
00389701012353R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012360R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012377R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012384R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
04251244500108DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500115DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500122DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500139DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500146DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30