FDA.reportPublic FDA data

Sonostik Single Port ClearSafe Catheter

Primary DI
00840155409927
Brand
Sonostik Single Port ClearSafe Catheter
Company
MEDSOURCE INTERNATIONAL LLC
Model
MS-87122
Catalog number
Not Applicable
Device description
Single Port ClearSafe, Closed Catheter 22G x 1”
Published
2021-09-17
Public version status
Update
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
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840155409934PackageGS150In Commercial Distribution
00840155409941PackageGS1200In Commercial Distribution
00840155409927PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840155409934008401554099348401554099340840155409934
00840155409941008401554099418401554099410840155409941
00840155409927008401554099278401554099270840155409927

GMDN Terms#

Term, Definition table
TermDefinition
Central venous catheter inside-out introduction setA collection of sterile, invasive devices intended to enable introduction of a central venous catheter (CVC) into an occluded vein (e.g., subclavian) by creating a puncture site from the inside of the vein under fluoroscopic guidance. It typically includes: an introducer sheath, for initial vascular access via a secondary vein (e.g., femoral); a semi-rigid, noncoring, endovascular guide sheath assembly with a distal side-hole, intended to navigate into, and be stabilized by, the vascular occlusion; a percutaneous needle-wire, intended to puncture the vein/tissue to exit at the skin surface; and a sheath for introduction of a CVC; the catheter is not included. This is a single-use device.

Regulatory Flags#

DUNS number
041674552
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840155400108MedSource Non-Rebreather MaskMS-25058-RCSNot Applicable2021-05-26
00840155400184MedSource Non-Rebreather MaskMS-25060-RCSNot Applicable2021-05-27
00840155400375MedSource Oxygen MaskMS-26041-RCSNot Applicable2021-05-28
00840155400412MedSource Oxygen MaskMS-26042-RCSNot Applicable2021-05-28
00840155408425MedSource BlanketMS-40521Not Applicable2021-07-07
00816703023617MedSource First Aid KitNORTH-349000Not Applicable2021-08-17
00816703023723MedSource BagsNORTH-678805EMNot Applicable2021-08-17
00816703023839MedSource First Aid WalletNORTH-67M08Not Applicable2021-08-25
00816703024034MedSource Packed BagsSH-B1311Not Applicable2021-08-25
00840155404304MedSource Body BagsMS-BOD200Not Applicable2021-07-28
00840155406094MedSource Emergency BlanketMS-B100Not Applicable2021-07-27
00840155406162MedSource Emergency BlanketMS-B200Not Applicable2021-07-27
00816703023853MedSource BagsNORTH-67M09Not Applicable2021-08-25
00816703023860MedSource BagsNORTH-67M10Not Applicable2021-08-25
00816703023938MedSource Packed BagsNORTH-90LGTRAUMNot Applicable2021-08-25
00816703023952MedSource Packed BagsNORTH-90TRAUMAENot Applicable2021-08-25
00816703024058MedSource First Aid KitSH-B1411Not Applicable2021-08-25
00816703024065MedSource Packed BagsSH-B1412Not Applicable2021-08-25
00816703027097MedSource BagsMS-TLS-3-BNot Applicable2021-08-16
00816703029473MedSource BagsMS-33360-RCSNot Applicable2021-08-03

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Primary DI, Brand, Company table
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10884450489922Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489939Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489946Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489953Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489960Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489977Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489984Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450495091Hydrophilic Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450510602Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10884450510640Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10884450510664Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10801902227109ARROWTELEFLEX INCORPORATEDDYB2026-09-03
00884450840597Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-27