FDA.reportPublic FDA data

EZ FLO

Primary DI
10850017403014
Brand
EZ FLO
Company
AIR-TITE PRODUCTS COMPANY, INC.
Model
NEZ16100
Catalog number
NEZ16100
Device description
"HYPODERMIC NEEDLE 16G X 1"""
Published
2020-04-15
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
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112057000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112057000KDL SYRINGES AND NEEDLEShanghai Kindly Enterprise Dev. Group Co.,2011-12-14FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850017403011PackageGS120In Commercial Distribution
30850017403018PackageGS15In Commercial Distribution
10850017403014PrimaryGS10
00850017403017Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085001740301120850017403011
3085001740301830850017403018
1085001740301410850017403014
00850017403017008500174030178500174030170850017403017

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.

Contacts#

Phone, Email table
PhoneEmail
(757) 340-2501atinfo@air-tite.com

Regulatory Flags#

DUNS number
002385425
Device count
100
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850017403724MinimLLMinimLL ONEMINI12025-04-01
20850017403721MinimLLMinimLL ONEMINI12025-04-01
10850017403007EZ FLONEZ15112NEZ151122020-04-15
10850017403021EZ FLONEZ16112NEZ161122020-04-15
10850017403038EZ FLONEZ17200NEZ172002020-04-15
10850017403045EZ FLONEZ18100NEZ181002020-04-15
10850017403052EZ FLONEZ18112NEZ181122020-04-15
10850017403069EZ FLONEZ18200NEZ182002020-04-15
10850017403076EZ FLONEZ19100NEZ191002020-04-15
10850017403083EZ FLONEZ19112NEZ191122020-04-15
10850017403090EZ FLONEZ20100NEZ201002020-04-15
10850017403106EZ FLONEZ20112NEZ201122020-04-15
10850017403113EZ FLONEZ21100NEZ211002020-04-15
10850017403120EZ FLONEZ21112NEZ211122020-04-15
10850017403137EZ FLONEZ21200NEZ212002020-04-15
10850017403144EZ FLONEZ22034NEZ220342020-04-15
10850017403151EZ FLONEZ22100NEZ221002020-04-15
10850017403168EZ FLONEZ22200NEZ222002020-04-15
10850017403175EZ FLONEZ22112NEZ221122020-04-15
10850017403182EZ FLONEZ22300NEZ223002020-04-15

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M99230403250120LCH3Livaclean HealthCarelife (usa) Inc.FMI2026-09-30
00850002860733Comfort EZ Pro DuoS.D.I. USA, INC.FMI2026-09-28
10192253005059MonojectCardinal Health 200, LLCFMI2026-09-24
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
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