FDA.report

PowerPICC Catheter with Sherlock Tip Positioning System (TPS) Stylet

Primary DI
10801741035569
Brand
PowerPICC Catheter with Sherlock Tip Positioning System (TPS) Stylet
Company
Bard Access Systems, Inc.
Model
9174118
Catalog number
9174118
Device description
PowerPICC Sherlock 4F Single-Lumen Polyurethane Catheter with Tip Locating System (TLS) Stylet. Nurse Basic Tray with Microintroducer
Published
2015-06-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LJSCatheter,intravascular,therapeutic,long-term greater than 30 days

Product Code Classifications

CodeDeviceSpecialtyClass
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10801741035569PackageGS15In Commercial Distribution
00801741035562PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174103556910801741035569
00801741035562008017410355628017410355620801741035562

GMDN Terms

TermDefinition
Peripherally-inserted central venous catheterA sterile, thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge4French
Length55Centimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)545-0890medical.services@crbard.com

Regulatory Flags

DUNS number
044611812
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
true
Sterilization required before use
false

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10801741231336CentroVena One1MB0R72161MB0R72162026-01-23
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