FDA.reportPublic FDA data

Liverty

Primary DI
00382903064663
Brand
Liverty
Company
Suzhou BD Medical Device Co., Ltd
Model
306466
Catalog number
306466
Device description
Liverty TIPS Access Set
Published
2022-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYBIntroducer, catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221440000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221440000Liverty™ TIPS Access SetBard Peripheral Vascular, Inc.2022-05-31DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382903064663PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382903064663003829030646633829030646630382903064663

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue biopsy procedure kit, non-medicatedA collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)562-0027medical.services@crbard.com

Regulatory Flags#

DUNS number
420025124
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50382903206181Pen Needle006811313868143206162023-04-24
50382903206174Pen Needle6811313868073206172022-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450439392Prelude IDeal™Merit Medical Systems, Inc.DYB2026-10-21
00884450840610Prelude Roadster™Merit Medical Systems, Inc.DYB2026-10-20
00821329003455GORE GUIDRA Steerable SheathGreatbatch LtdDYB2026-10-14
00821329003462GORE GUIDRA Steerable SheathGreatbatch LtdDYB2026-10-14
00733132658855GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658862GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658879GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658886GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658893GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658909GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658916GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658923GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658930GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658947GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658954GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658961GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658978GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658985GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658992GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659005GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659012GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659029GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659036GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659043GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659050GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659067GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00850291007475Triever LA Transseptal SheathInari Medical, Inc.DYB2024-04-15
00810123710430ClotTriever SheathInari Medical, Inc.DYB2023-12-15
00733132629985GORE DRYSEAL FLEX Introducer SheathW. L. Gore & Associates, Inc.DYB2023-05-25
00733132628285GORE DRYSEAL FLEX Introducer SheathW. L. Gore & Associates, Inc.DYB2020-07-11