FDA.report

Nautilus Delta Tip Confirmation System (TCS)

Primary DI
00801741137075
Brand
Nautilus Delta Tip Confirmation System (TCS)
Company
Bard Access Systems, Inc.
Model
9770320X
Catalog number
9770320X
Device description
Refurbished Patient Module
Published
2017-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00801741137075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741137075008017411370758017411370750801741137075

GMDN Terms

TermDefinition
Central venous catheter navigation system, electrocardiographicAn assembly of noninvasive devices intended to use electrocardiographic (ECG) data to assist guidance and positioning of a central venous catheter [e.g., peripherally-inserted central catheter (PICC), central venous catheter (CVC), haemodialysis catheter]. It includes a portable battery-powered control unit, ECG cable(s), and ECG lead(s). The catheter (not included) is used as an intravascular electrode, with the guidewire or intraluminal saline used as a conductor. The control unit processes ECG signals and sends them to a separate off-the-shelf device (e.g., smartphone), whereby intravascular ECG changes indicate catheter position typically in conjunction with skin surface ECG data.

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-18 Degrees Celsius40 Degrees Celsius

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
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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 DIBrandModelCatalogPublished
00801741036712Groshong771070077107002015-09-24
00801741036729Groshong771155077115502015-09-24
00801741037696Groshong772495077249502015-09-24
00801741037719Groshong774155077415502015-09-24
10801741239356PowerPICC Sherlock 3CGCK001067ACK001067A2026-03-11
10801741239363PowerPICC ProvenaCK001068ACK001068A2026-03-11
10801741239370PowerPICC ProvenaCK001069ACK001069A2026-03-11
10801741239271MiniLocCPA00072CPA000722026-02-26
10801741238830PowerPICC Provena SOLOCK001091CK0010912026-02-11
00801741038464Niagara Slim-Cath catheter543215054321502015-12-04
00801741038471Niagara Slim-Cath Catheter543220054322002015-11-20
00801741038488Niagara Slim-Cath catheter543224054322402015-12-04
00801741045141Niagara Slim-Cath catheter543412054341202015-11-20
00801741045158Niagara Slim-Cath catheter543415054341502015-11-06
10801741231275CentroVena One1K0R72161K0R72162026-01-23
10801741231282CentroVena One1K0R72201K0R72202026-01-23
10801741231305CentroVena One1K0R73161K0R73162026-01-23
10801741231312CentroVena One1K0R73201K0R73202026-01-23
10801741231329CentroVena One1K0R73301K0R73302026-01-23
10801741231336CentroVena One1MB0R72161MB0R72162026-01-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10801741239356PowerPICC Sherlock 3CGBard Access Systems, Inc.LJS2026-03-11
10801741239363PowerPICC ProvenaBard Access Systems, Inc.LJS2026-03-11
10801741239370PowerPICC ProvenaBard Access Systems, Inc.LJS2026-03-11
50884908135782PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST)Medical Components, Inc.LJS2026-02-17
50884908143855PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST)Medical Components, Inc.LJS2026-02-17
50884908143862PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST)Medical Components, Inc.LJS2026-02-17
50884908143879PRO-PICC® CT PRESSURE INJECTABLE CVC (ISOPLAST)Medical Components, Inc.LJS2026-02-17
50884908152703PRO-PICC® CTMedical Components, Inc.LJS2026-02-17
50884908154714PRO-PICC® CTMedical Components, Inc.LJS2026-02-17
50884908154721PRO-PICC® CTMedical Components, Inc.LJS2026-02-17
50884908160234PRO-PICC® CTMedical Components, Inc.LJS2026-02-17
50884908160258PRO-PICC® CTMedical Components, Inc.LJS2026-02-17
50884908174361PRO-PICC® CTMedical Components, Inc.LJS2026-02-17
50884908184094VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184100VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184117VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184124VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184278VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184285VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184292VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184308VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184315VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
50884908184322VASCU-PICC® AND MIDLINE CATHETERSMedical Components, Inc.LJS2026-02-13
10801741238830PowerPICC Provena SOLOBard Access Systems, Inc.LJS2026-02-11
50884908062415VASCU-PICC® (TAPERLESS)Medical Components, Inc.LJS2026-01-31
50884908062446VASCU-PICC® (TAPERLESS)Medical Components, Inc.LJS2026-01-31
50884908062477VASCU-PICC® (TAPERLESS)Medical Components, Inc.LJS2026-01-31
50884908062729VASCU-PICC® (TAPERLESS)Medical Components, Inc.LJS2026-01-31
50884908062804MEDCOMP PRO-PICC WITH VALVE TECHNOLOGYMedical Components, Inc.LJS2026-01-31
50884908062811MEDCOMP PRO-PICC WITH VALVE TECHNOLOGYMedical Components, Inc.LJS2026-01-31