FDA.reportPublic FDA data

Able Central Venous Catheter Triple Lumen 5.5F*5cm

Primary DI
26938634490325
Brand
Able Central Venous Catheter Triple Lumen 5.5F*5cm
Company
Guangdong Baihe Medical Technology Co., Ltd.
Model
02X-FV-3521
Published
2016-09-22
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
FOZCatheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070451000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070451000ABLE CENTRAL VENOUS CATHETERFoshan Nanhai Bai HE Medical Technology Co., Ltd.2007-07-31FOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16938634490328PackageGS110In Commercial Distribution
26938634490325PackageGS140In Commercial Distribution
06938634490321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693863449032816938634490328
2693863449032526938634490325
06938634490321069386344903216938634490321

GMDN Terms#

Term, Definition table
TermDefinition
Central venous catheterA sterile, flexible tube intended to be introduced into a neck or thoracic vein and often advanced into the superior vena cava for various infusion/aspiration procedures (i.e., non-dedicated) including the intravenous administration of nutrients, fluids, chemotherapeutic agents or other drugs, and blood sampling or delivery; it may also be used to monitor venous pressure. The proximal end of this central venous catheter (CVC) is typically fixed to the patient for long-term use. It may include supportive devices associated with introduction (e.g., guidewire, introducer); it is not primarily intended for extracorporeal blood therapies such as haemodialysis. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
547055364
Device count
1
DM exempt
false
Premarket exempt
false
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06938634454309Disposable Hemodialysis Access Catheter Set Single Lumen8F*10cmFH-18132016-09-22
06938634454422Disposable Hemodialysis Access Catheter Set Single Lumen7F*10cmFH-17132016-09-22
06938634460133ABLE CENTRAL VENOUS CATHETERTriple Lumen 7F*30cmFV-37282016-09-22
06938634460171ABLE CENTRAL VENOUS CATHETERTriple Lumen 7F*13cmFC-37242016-09-22
06938634461857ABLE CENTRAL VENOUS CATHETERDouble Lumen 5F*10cmFC-25232016-09-22
06938634463035ABLE CENTRAL VENOUS CATHETERDouble Lumen 7F*10cmFV-27232016-09-20
06938634463196ABLE CENTRAL VENOUS CATHETERSingle Lumen 16G*10cmFV-15232016-09-22
06938634469624Disposable Hemodialysis Access Catheter Set Double Lumen 14F*20cmFR-24162016-09-20
06938634469662Disposable Hemodialysis Access Catheter Set Double Lumen14F*16cmFR-24152016-09-20
06938634469709Disposable Hemodialysis Access Catheter Set Double Lumen 14F*15cmFR-2419152016-09-20
06938634469815Disposable Hemodialysis Access Catheter Set Double Lumen12F*20cmFR-22562016-09-22
06938634469891Disposable Hemodialysis Access Catheter Set Double Lumen12F*16cmFR-22552016-09-22
06938634469938Disposable Hemodialysis Access Catheter Set Double Lumen12F*15cmFR-2259152016-09-22
06938634469976Disposable Hemodialysis Access Catheter Set Double Lumen12F*13cmFR-22542016-09-22
06938634469983Disposable Hemodialysis Access Catheter Set Double Lumen12F*13cmFR-22142016-09-20
06938634470491Disposable Hemodialysis Access Catheter Set Double Lumen 11.5F*20cmFR-21162016-09-22
06938634470514Disposable Hemodialysis Access Catheter Set Double Lumen11.5F*20cmFH-21162016-09-22
06938634470583Disposable Hemodialysis Access Catheter Set Double Lumen11.5F*16cmFH-21552016-09-22
06938634470590Disposable Hemodialysis Access Catheter Set Double Lumen11.5F*16cmFH-21152016-09-22
06938634470613Disposable Hemodialysis Access Catheter Set Double Lumen11.5F*15cmFR-2119152016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902219210ARROWTELEFLEX INCORPORATEDFOZ2026-08-03
10801902130546ARROWTELEFLEX INCORPORATEDFOZ2026-08-01
10801902218084ARROWTELEFLEX INCORPORATEDFOZ2026-08-01
10801902218404ARROWTELEFLEX INCORPORATEDFOZ2026-08-01
10801902224436ARROWTELEFLEX INCORPORATEDFOZ2026-08-01
00382903935314NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935321NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935338NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935345NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935352NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935369NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935376NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935383NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
10801902167344ARROWTELEFLEX INCORPORATEDFOZ2026-07-30
10801902129700ARROWTELEFLEX INCORPORATEDFOZ2026-07-28
10801902167351ARROWTELEFLEX INCORPORATEDFOZ2026-07-28
10801902167894ARROWTELEFLEX INCORPORATEDFOZ2026-07-28
10801902226379ARROWTELEFLEX INCORPORATEDFOZ2026-07-14
10801902226386ARROWTELEFLEX INCORPORATEDFOZ2026-07-14
00850073657003Ruby Intravascular CatheterVenocare, Inc.FOZ2026-04-08
10884521832930MAHURKARMozarc Medical US LLCFOZ2022-11-03
10884521832985MAHURKARMozarc Medical US LLCFOZ2022-11-03
08032248007123SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007130SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007147SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007154SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007161SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007178SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007185SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007192SOL CARE T DELTA MED SPAFOZ2021-03-30