FDA.reportPublic FDA data

Needle, Hypodermic, Single Lumen

Primary DI
00816513020141
Brand
Needle, Hypodermic, Single Lumen
Company
MPS MEDICAL, INC
Model
19B
Published
2016-05-23
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
K972538000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K972538000FLOW-EZE BLUNT CANNULA (1999BC)Acacia, Inc.1998-07-15FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816513020148PackageGS1100In Commercial Distribution
00816513020141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081651302014810816513020148
00816513020141008165130201418165130201410816513020141

GMDN Terms#

Term, Definition table
TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). 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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Primary DI, Brand, Company table
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10809160538913HalyardMEDICAL ACTION INDUSTRIES INC.FMI2026-09-24
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MHC18290272EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18310472EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18313672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18320872EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18323672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
00850091070013CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070235CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070242CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
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00814965020481Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020504Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020528Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020542Precision PointGold Coast Medical Supply, LPFMI2026-08-26