FDA.report

MEDLINE

Primary DI
10197344039852
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
HNY20075
Catalog number
HNY20075
Device description
HUBER INFUSION SET,Y-SITE, 20G X 0.
Published
2024-10-11
Public version status
Update
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
K251138000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K230715000Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd.2023-06-08PTI
K251138000Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd.2025-05-13PTI

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20197344039859PackageGS120In Commercial Distribution
30197344039856PackageGS1200In Commercial Distribution
10197344039852PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019734403985920197344039859
3019734403985630197344039856
1019734403985210197344039852

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.

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
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10
20080196260130MEDLINEMDT013629MDT0136292016-10-14

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
10197344039746MEDLINEMEDLINE INDUSTRIES, INC.PTI2024-10-11
10197344039784MEDLINEMEDLINE INDUSTRIES, INC.PTI2024-10-11
10197344039838MEDLINEMEDLINE INDUSTRIES, INC.PTI2024-10-11
10197344039845MEDLINEMEDLINE INDUSTRIES, INC.PTI2024-10-11
10197344039869MEDLINEMEDLINE INDUSTRIES, INC.PTI2024-10-11
10197344039876MEDLINEMEDLINE INDUSTRIES, INC.PTI2024-10-11
10197344039883MEDLINEMEDLINE INDUSTRIES, INC.PTI2024-10-11
10197344039890MEDLINEMEDLINE INDUSTRIES, INC.PTI2024-10-11
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