FDA.reportPublic FDA data

MEDLINE

Primary DI
10197344039814
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
HNX22150
Catalog number
HNX22150
Device description
HUBER INFUSION SET,NO Y-SITE,20G X 1
Published
2024-09-27
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
20197344039811PackageGS120In Commercial Distribution
30197344039818PackageGS110In Commercial Distribution
10197344039814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019734403981120197344039811
3019734403981830197344039818
1019734403981410197344039814

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
10197344144181MEDLINERTACIBDHPRTACIBDHP2026-08-07
10197344169429MEDLINEMSCSRG97310MSCSRG973102026-08-07
10197344169436MEDLINEMSCSRG97314MSCSRG973142026-08-07
10195327188955NAMICDYNJGWIRE20LDYNJGWIRE20L2022-08-04
10195327279776MedlineDNSC145169DNSC1451692023-06-13
10195327301057NAMICDYNJHWIRE100DYNJHWIRE1002023-01-29
10195327301590NAMICDYNJHWIRE101DYNJHWIRE1012023-01-29
10195327301606NAMICDYNJHWIRE102DYNJHWIRE1022023-01-29
10195327301613NAMICDYNJHWIRE103DYNJHWIRE1032023-01-29
10195327301620NAMICDYNJHWIRE104DYNJHWIRE1042023-01-29
10195327301637NAMICDYNJHWIRE105DYNJHWIRE1052023-01-29
10195327302153NAMICDYNJHWIRE106DYNJHWIRE1062023-01-29
10195327302184NAMICDYNJHWIRE107DYNJHWIRE1072023-01-29
10195327302191NAMICDYNJHWIRE108DYNJHWIRE1082023-01-29
10195327302207NAMICDYNJHWIRE109DYNJHWIRE1092023-01-29
10195327302214NAMICDYNJHWIRE110DYNJHWIRE1102023-01-29
10195327305987NAMICDYNJHWIRE111DYNJHWIRE1112023-01-29
10195327305994NAMICDYNJHWIRE112DYNJHWIRE1122023-01-29
10195327306007NAMICDYNJHWIRE113DYNJHWIRE1132023-01-29
10195327306014NAMICDYNJHWIRE114DYNJHWIRE1142023-05-21

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