FDA.reportPublic FDA data

One-Step™

Primary DI
20884450298804
Brand
One-Step™
Company
Merit Medical Systems, Inc.
Model
00884450298800
Catalog number
OSC-6F-15T/B
Published
2019-07-23
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
GBXCATHETER, IRRIGATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBXCatheter, IrrigationGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450298807PackageGS15In Commercial Distribution
20884450298804PackageGS122In Commercial Distribution
00884450298800PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445029880710884450298807
2088445029880420884450298804
00884450298800008844502988008844502988000884450298800

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound/centesis drainage receptacleA sterile container designed to be connected to an invasive drain/drainage catheter (not included) to collect fluids or purulent material being removed during drainage of a body cavity, a closed-wound, and/or the bile duct; it is not intended for drainage of cerebrospinal fluid (CSF) or blood. It is typically in the form of a bottle, bag, or bulb with fluid volume markers, and might include a hand-operated pump (e.g., suction bulb) and tubing; it does not include any invasive components or powered devices. This is a single-use device.

Device Sizes#

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

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
00884450392898SCOUT MD™Initial ReleaseMDS10A-012026-05-23
00884450392904SCOUT MD™Initial ReleaseMDS10B-012026-05-23
00884450392911SCOUT MD™Initial ReleaseMDS10C-012026-05-23
00884450393383SCOUT MD™Initial ReleaseMDS75SA-012026-05-23
00884450399965SCOUT MD™Initial ReleaseMDS75SM-012026-05-23
00884450435120Merit Medical®Initial ReleaseK09-10345A2026-05-22
00884450435533Merit Medical®Initial ReleaseK07-00112C2026-05-23
00884450437049Merit Medical®Initial ReleaseK11-01136C2026-05-23
00884450437162Merit Medical®Initial ReleaseK09-10786C2026-05-22
00884450441350Merit Medical®Initial ReleaseK09-14004B2026-05-23
00884450474587Merit Medical®Initial ReleaseK12T-127142026-05-23
00884450392928SCOUT MD™Initial ReleaseMDS10M-012026-05-21
00884450394427SCOUT MD™Initial ReleaseMDS75SB-012026-05-21
00884450399170SCOUT MD™Initial ReleaseMDS75SC-012026-05-21
00884450436066Merit Medical®Initial ReleaseK08-02870A2026-05-21
00884450436172Merit Medical®Initial ReleaseK09-14009A2026-05-21
00884450122679Merit Medical®Initial ReleaseK08-02092B2026-05-20
00884450180075Merit Medical®Initial ReleaseK09-13303A2026-05-20
00884450424636Merit Medical®Initial ReleaseK09-13719B2026-05-20
00884450437988Merit Disposal Depot™Initial ReleaseK10-00577B2026-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196995998MEDLINEMEDLINE INDUSTRIES, INC.GBX2024-12-12
10080196128839MedlineMEDLINE INDUSTRIES, INC.GBX2023-12-27
10080196997633MedlineMEDLINE INDUSTRIES, INC.GBX2023-12-27
10801902210408ARROWTELEFLEX INCORPORATEDGBX2022-11-09
10801902194005ARROWTELEFLEX INCORPORATEDGBX2022-11-08
08034139292823Thoracic Catheter, Straight Fr 18REDAX SPAGBX2021-05-07
08034139292830Thoracic Catheter, Straight Fr 21REDAX SPAGBX2021-05-07
08034139292847Thoracic Catheter, Straight Fr 24REDAX SPAGBX2021-05-07
08034139292861Thoracic Catheter, Straight Fr 30REDAX SPAGBX2021-05-07
08034139292878Thoracic Catheter, Straight Fr 33REDAX SPAGBX2021-05-07
08034139293806Thoracic Catheter, Angled Fr 30REDAX SPAGBX2021-05-07
08034139293813Thoracic Catheter, Angled Fr 33REDAX SPAGBX2021-05-07
08034139294544Flat Drain 3/4 type Jackson-Pratt 4x10 mmREDAX SPAGBX2021-05-07
08034139294568Flat Drain type Jackson-Pratt 4x10 mmREDAX SPAGBX2021-05-07
08034139294575Flat Drain type Jackson-Pratt w/trocar 4x10 mmREDAX SPAGBX2021-05-07
08034139294582Flat Drain type Jackson-Pratt 4x13 mmREDAX SPAGBX2021-05-07
08034139294599Flat Drain type Jackson-Pratt w/trocar 4x13 mmREDAX SPAGBX2021-05-07
08034139294629Round Drain type Jackson-Pratt Fr 7REDAX SPAGBX2021-05-07
08034139294643Round Drain type Jackson-Pratt Fr 10REDAX SPAGBX2021-05-07
08034139294650Round Drain type Jackson-Pratt w/trocar Fr 10REDAX SPAGBX2021-05-07
08034139294698Round Drain type Jackson-Pratt w/trocar Fr 15REDAX SPAGBX2021-05-07
08034139294933Spiral Drain Round Fluted Drain w/trocar Fr 10REDAX SPAGBX2021-05-07
08034139294940Spiral Drain Round Fluted Drain w/trocar Fr 15REDAX SPAGBX2021-05-07
08034139294964Spiral Drain Round Fluted Drain w/trocar Fr 12REDAX SPAGBX2021-05-07
08034139294971Spiral Drain Round Fluted Drain Fr 7REDAX SPAGBX2021-05-07
08034139295008Spiral Drain Round Fluted Drain Fr 10REDAX SPAGBX2021-05-07
08034139295022Spiral Drain Round Fluted Drain Fr 15REDAX SPAGBX2021-05-07
08034139295039Spiral Drain Round Fluted Drain Fr 19REDAX SPAGBX2021-05-07
08034139295053Spiral Drain Round Fluted Drain Fr 24REDAX SPAGBX2021-05-07
08034139295060Flat Fluted Drain 4x10 mmREDAX SPAGBX2021-05-07