FDA.report

MEDLINE

Primary DI
30197344039764
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
HNX20075
Catalog number
HNX20075
Device description
HUBER NEEDLE,NO Y-SITE,20G X 0.75
Published
2024-05-13
Public version status
New
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
PTINon-coring (Huber) needle

Product Code Classifications

CodeDeviceSpecialtyClass
PTINon-Coring (Huber) NeedleGeneral Hospital2

Premarket Submissions

SubmissionSupplement
K230715000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K230715000Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd.2023-06-08PTI

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20197344039767PackageGS120In Commercial Distribution
30197344039764PackageGS110In Commercial Distribution
10197344039760PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019734403976720197344039767
3019734403976430197344039764
1019734403976010197344039760

GMDN Terms

TermDefinition
Vascular port administration setA collection of devices designed to conduct fluids from an intravenous (IV) fluid container to a patient's venous system via a previously implanted injection/infusion port. It typically includes a noncoring needle designed with a lateral hole (side-hole), tubing, connectors, chambers, clamps and may include an injection placement aid. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep dry. Keep product upright. Protect from freezing. Avoid excessive heat.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
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
true
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 DIBrandModelCatalogPublished
10080196163885MEDLINENONTH100BNONTH100B2026-03-24
10884389110003MEDLINECRI5001BCRI5001B2026-03-24
10884389110010MEDLINECRI5000BCRI5000B2026-03-24
10884389110072MEDLINENONTH200BNONTH200B2026-03-24
30193489036224MEDLINEMDSE2RDCAMDSE2RDCA2022-12-10
30193489036248MEDLINEMDSE2RDCPMDSE2RDCP2022-12-10
30193489036262MEDLINEMDSE2X2CAMDSE2X2CA2022-12-10
40888277170897MEDLINEFG1501FG15012026-03-20
40888277170972MEDLINEFG1503FG15032026-03-20
40888277358455MEDLINEMPHPN315MPHPN3152026-03-19
40888277358462MEDLINEMPHPN318MPHPN3182026-03-19
20197344009807HUDSON RCIHUD2417HUD24172026-03-19
20080196286789MEDLINEMDT2168282MDT21682822016-10-14
20080196765574MEDLINE INDUSTRIES, INC.NONLV200NONLV2002025-05-28
10197344010264HUDSON RCIHUD1846HUD18462026-03-19
20884389108199MEDLINE INDUSTRIES, INC.NONLV200XXXLNONLV200XXXL2024-03-05
20884389108229MEDLINENONLV200XXLNONLV200XXL2025-05-27
20884389155360MEDLINENONLV240NONLV2402025-05-27
20884389155377MEDLINENONLV240XLNONLV240XL2025-05-27
20888277336893MEDLINENON50240NON502402025-05-27

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10801741235235PowerLoc MaxBard Access Systems, Inc.PTI2025-04-10
10801741235242PowerLoc MaxBard Access Systems, Inc.PTI2025-04-10
20801741235256PowerLoc MaxBard Access Systems, Inc.PTI2025-04-10
10801741235266Safe StepBard Access Systems, Inc.PTI2025-04-10
10801741235280Safe StepBard Access Systems, Inc.PTI2025-04-10
10801741232357AllPoints Port Access System PowerLoc MaxBard Access Systems, Inc.PTI2024-12-05
10801741232364AllPoints Port Access System PowerLoc MaxBard Access Systems, Inc.PTI2024-12-05
10801741232371AllPoints Port Access System PowerLoc MaxBard Access Systems, Inc.PTI2024-12-05
10801741232395AllPoints Port Access System PowerLoc MaxBard Access Systems, Inc.PTI2024-12-05
10801741232470AllPoints Port Access System SafeStepBard Access Systems, Inc.PTI2024-12-05
10801741232487AllPoints Port Access System SafeStepBard Access Systems, Inc.PTI2024-12-05
10801741232494AllPoints Port Access System SafeStepBard Access Systems, Inc.PTI2024-12-05
10801741232500AllPoints Port Access System SafeStepBard Access Systems, Inc.PTI2024-12-05
20197344039736MEDLINEMEDLINE INDUSTRIES, INC.PTI2024-10-11
20197344039743MEDLINEMEDLINE INDUSTRIES, INC.PTI2024-10-11
30197344039757MEDLINEMEDLINE INDUSTRIES, INC.PTI2024-10-11
20197344039781MEDLINEMEDLINE INDUSTRIES, INC.PTI2024-10-11
30197344039795MEDLINEMEDLINE INDUSTRIES, INC.PTI2024-10-11
30197344039801MEDLINEMEDLINE INDUSTRIES, INC.PTI2024-10-11
20197344039828MEDLINEMEDLINE INDUSTRIES, INC.PTI2024-10-11
20197344039835MEDLINEMEDLINE INDUSTRIES, INC.PTI2024-10-11
20197344039842MEDLINEMEDLINE INDUSTRIES, INC.PTI2024-10-11
30197344039856MEDLINEMEDLINE INDUSTRIES, INC.PTI2024-10-11
20197344039866MEDLINEMEDLINE INDUSTRIES, INC.PTI2024-10-11
30197344039870MEDLINEMEDLINE INDUSTRIES, INC.PTI2024-10-11
30197344039887MEDLINEMEDLINE INDUSTRIES, INC.PTI2024-10-11
20197344039897MEDLINEMEDLINE INDUSTRIES, INC.PTI2024-10-11
20197344039811MEDLINEMEDLINE INDUSTRIES, INC.PTI2024-09-27
20197344039903MEDLINEMEDLINE INDUSTRIES, INC.PTI2024-09-27
20197344039774MEDLINEMEDLINE INDUSTRIES, INC.PTI2024-07-29