FDA.reportPublic FDA data

MEDLINE

Primary DI
10197344039777
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
HNX20100
Catalog number
HNX20100
Device description
HUBER INFUSION SET,NO Y-SITE,20G X 1
Published
2024-07-29
Public version status
Update
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
PTINon-coring (Huber) needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTINon-Coring (Huber) NeedleGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230715000
K251138000

Premarket Details#

Submission, Supplement, Device table
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#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20197344039774PackageGS120In Commercial Distribution
30197344039771PackageGS110In Commercial Distribution
10197344039777PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019734403977420197344039774
3019734403977130197344039771
1019734403977710197344039777

GMDN Terms#

Term, Definition table
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#

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
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
10193489006728MEDLINEURO12575URO125752026-10-23
10197344219261MEDLINEDYNDSCL1500RDYNDSCL1500R2026-10-23
10653160395461MEDLINEDYNDC3514BDYNDC3514B2026-10-24
10653160395713MEDLINEEBSI1586BEBSI1586B2026-10-24
10653160395720MEDLINEDYNDC3637DYNDC36372026-10-24
10653160395751MEDLINEECVC8657ECVC86572026-10-24
10653160395782MEDLINEEBSI1426BEBSI1426B2026-10-24
10653160395799MEDLINEECVC2440CECVC2440C2026-10-24
10653160395805MEDLINEEBSI1687AEBSI1687A2026-10-24
10653160395812MEDLINEEBSI1356AEBSI1356A2026-10-24
10653160395850MEDLINEECVC7295AECVC7295A2026-10-24
10653160395867MEDLINEEBSI1590AEBSI1590A2026-10-24
10653160395881MEDLINEECVC2770AECVC2770A2026-10-24
10653160395911MEDLINEEBSI1529AEBSI1529A2026-10-24
10653160395959MEDLINEDYNDV2823DYNDV28232026-10-24
00197344133850MEDLINEFRES2502FRES25022026-06-09
00197344133874MEDLINEFRES2503FRES25032026-06-09
00197344133898MEDLINEFRES2504FRES25042026-06-09
10884389194775MEDLINEMDS9911MDS99112016-10-14
10884389194799MEDLINEMDS9911MQMDS9911MQ2016-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04987488111298K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
04987488111304K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
04987488111311K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
04987488111328K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
04987488111335K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
04987488111342K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
04987488111359K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
04987488111366K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
04987488111373K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
04987488111380K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
04987488111397K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
04987488111403K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
00801741239403SafeStepBard Access Systems, Inc.PTI2026-04-07
00801741235238PowerLoc MaxBard Access Systems, Inc.PTI2025-04-10
00801741235245PowerLoc MaxBard Access Systems, Inc.PTI2025-04-10
00801741235252PowerLoc MaxBard Access Systems, Inc.PTI2025-04-10
00801741235269Safe StepBard Access Systems, Inc.PTI2025-04-10
00801741235283Safe StepBard Access Systems, Inc.PTI2025-04-10
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
00801741232350AllPoints Port Access System PowerLoc MaxBard Access Systems, Inc.PTI2024-12-05
00801741232367AllPoints Port Access System PowerLoc MaxBard Access Systems, Inc.PTI2024-12-05
00801741232374AllPoints Port Access System PowerLoc MaxBard Access Systems, Inc.PTI2024-12-05
00801741232398AllPoints Port Access System PowerLoc MaxBard Access Systems, Inc.PTI2024-12-05
00801741232473AllPoints Port Access System SafeStepBard Access Systems, Inc.PTI2024-12-05
00801741232480AllPoints Port Access System SafeStepBard Access Systems, Inc.PTI2024-12-05
00801741232497AllPoints Port Access System SafeStepBard Access Systems, Inc.PTI2024-12-05