FDA.reportPublic FDA data

Kronner Side-Kick High Pressure Gas Line Set

Primary DI
00856589007073
Brand
Kronner Side-Kick High Pressure Gas Line Set
Company
KRONNER PROTOTYPES, INCORPORATED
Model
HPL1-BL1-V2
Device description
One set contains:1 - Branched line with two male luer-lock fittings on the distal end and one luer-lock female fitting with a luer activated valve on the proximal end. Length: 96 inches.1 - Straight gas line, whit one male luer-lock fitting on the distal end and one luer-lock female fitting with a luer activated valve on the proximal end. Length: 96 inches.
Published
2017-05-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LKFCannula, Manipulator/Injector, Uterine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKFCannula, Manipulator/Injector, UterineObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130758000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130758000KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDERKronner Prototypes, Inc.2013-12-11LKF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856589007080PackageGS125In Commercial Distribution
00856589007073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856589007080008565890070808565890070800856589007080
00856589007073008565890070738565890070730856589007073

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration tubing extension setA collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.

Regulatory Flags#

DUNS number
091301184
Device count
1
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856589007011Kronner Low Profile Scope Holder Gas Line Set12017-04-21
00856589007080Kronner Side-Kick High Pressure Gas Line SetHPL1-BL1-V22017-05-26
00856589007035VCM 40VCM-402017-05-26
00856589007042VCM 45VCM-452017-05-26
00856589007059VCM 50VCM-502017-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850011427378Titus Medical LLCTITUS MEDICAL LLCLKF2026-04-20
00850011427385TITUS MEDICALTITUS MEDICAL LLCLKF2026-04-19
20859500005008FemVueFEMASYS INC.LKF2026-01-06
30859500005005FemVueFEMASYS INC.LKF2026-01-06
00888937029697ALLY II UPS (Uterine Positioning System)Coopersurgical, Inc.LKF2025-12-18
00198506017919ELMED INCORPORATEDELMED INCORPORATEDLKF2025-08-11
00198506017704ELMED INCORPORATEDELMED INCORPORATEDLKF2025-07-08
00860010540930Rejoni Ribbed CatheterRejoni, Inc.LKF2025-02-18
10860010540937Rejoni Ribbed CatheterRejoni, Inc.LKF2025-02-18
00840306835360Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835377Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835384Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835391Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835407Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835544Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835865Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
04719894432892BiotequeBioteque Taiwan Ltd.LKF2024-12-06
04719894432908BiotequeBioteque Taiwan Ltd.LKF2024-12-06
04719894432915BiotequeBioteque Taiwan Ltd.LKF2024-12-06
04719894432922BiotequeBioteque Taiwan Ltd.LKF2024-12-06
00840306826177Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2024-05-08
00840306826184Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2024-05-08
04719894432571BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432588BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432595BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432601BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432618BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432625BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432755BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432762BiotequeBioteque Taiwan Ltd.LKF2024-04-08