FDA.reportPublic FDA data

Huber Needle Extension Set

Primary DI
00816513023517
Brand
Huber Needle Extension Set
Company
MPS MEDICAL, INC
Model
TID - H
Published
2016-12-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K982047000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982047000MPS HUBER NEEDLE EXTENSION SETMedical Product Specialists1998-07-21FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816513023517PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816513023517008165130235178165130235170816513023517

GMDN Terms#

Term, Definition table
TermDefinition
Fluid transfer set, general-purposeA collection of sterile devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079636164
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816513022701Set, I.V. Fluid Transfer17789HP3M-10PK2019-03-12
00816513023418Set, I.V. Fluid TransferNP-0052019-03-12
00816513023456Set, I.V. Fluid TransferNP-0062019-03-12
00816513023463Single Lead High Volume Pump Chamber SetG82721-MF2019-03-12
00816513023562Single Lead High Volume Pump Chamber SetG827331-M2019-03-12
00816513023883Set, I.V. Fluid TransferKMI-LTP2019-03-12
00816513024101Set, I.V. Fluid TransferHR-0452019-03-12
00816513024545Dual Lead High Volume Pump Chamber SetG82762-M2019-09-06
00816513024552Triple Lead High Volume Pump Chamber SetG82763-M2019-09-06
00816513024569Single lead High Volume Pump Chamber Set w/WeightG82713-M2019-09-30
00816513024873Set, I.V. Fluid Transfer19DTP2020-02-07
00816513025016Set, I.V. Fluid TransferNP-0192020-02-28
00816513025023Set, I.V. Fluid TransferNP-0202020-02-28
00816513025030Set, I.V. Fluid TransferNP-0212020-04-08
00816513020011Set, I.V. Fluid Transfer1 PHARM-62016-05-23
00816513020028Set, I.V. Fluid Transfer1 PHARM-6FG2016-05-23
00816513020035Set, I.V. Fluid Transfer17787HP3M2016-05-23
00816513020042Set, I.V. Fluid Transfer17788HP3M2016-05-23
00816513020059Set, I.V. Fluid Transfer17789HP2016-05-26
00816513020066Set, I.V. Fluid Transfer17789HP3M2016-05-23

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