FDA.report

MEDLINE

Primary DI
20197344039828
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
HNY19075
Catalog number
HNY19075
Device description
HUBER INFUSION SET,Y-SITE,19G X 0.
Published
2024-10-11
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
20197344039828PackageGS120In Commercial Distribution
30197344039825PackageGS1200In Commercial Distribution
10197344039821PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019734403982820197344039828
3019734403982530197344039825
1019734403982110197344039821

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

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