FDA.reportPublic FDA data

EZ FLO

Primary DI
20850017403004
Brand
EZ FLO
Company
AIR-TITE PRODUCTS COMPANY, INC.
Model
NEZ15112
Catalog number
NEZ15112
Device description
HYPODERMIC NEEDLE 15G X 1-1/2"
Published
2020-04-15
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

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
20850017403004PackageGS120In Commercial Distribution
30850017403001PackageGS15In Commercial Distribution
10850017403007PrimaryGS10
00850017403000Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085001740300420850017403004
3085001740300130850017403001
1085001740300710850017403007
00850017403000008500174030008500174030000850017403000

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

Contacts#

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

Regulatory Flags#

DUNS number
002385425
Device count
100
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850017403724MinimLLMinimLL ONEMINI12025-04-01
20850017403721MinimLLMinimLL ONEMINI12025-04-01
10850017403007EZ FLONEZ15112NEZ151122020-04-15
10850017403014EZ FLONEZ16100NEZ161002020-04-15
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

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10809160538913HalyardMEDICAL ACTION INDUSTRIES INC.FMI2026-09-24
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MHC18290272EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
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MHC18313672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
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