FDA.reportPublic FDA data

AHS

Primary DI
B031AHS1825RN0
Brand
AHS
Company
American Health Service Sales Corporation
Model
AHS1825RN
Device description
NEEDLE,18 X 1
Published
2016-03-31
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

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
K050999000
K112057000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050999000YI XIN STERILE SYRINGE FOR SINGLE USEJiangxi Sanxin (Eversincere) Medical Devices Group2005-09-02FMF
K112057000KDL SYRINGES AND NEEDLEShanghai Kindly Enterprise Dev. Group Co.,2011-12-14FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B031AHS1825RN1PackageHIBCC100In Commercial Distribution
B031AHS1825RN2PackageHIBCC10000In Commercial Distribution
B031AHS1825RN0PrimaryHIBCC0

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.

Regulatory Flags#

DUNS number
556115970
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B031AH01T25160AHSAH01T25162016-03-31
B031AH01T27130AHSAH01T27132016-03-31
B031AH03L18250AHSAH03L18252016-03-31
B031AH03L18380AHSAH03L18382016-03-31
B031AH03L20250AHSAH03L20252016-03-31
B031AH03L20380AHSAH03L20382016-03-31
B031AH03L21250AHSAH03L21252016-03-31
B031AH03L22190AHSAH03L22192016-03-31
B031AH03L22250AHSAH03L22252016-03-31
B031AH03L22380AHSAH03L22382016-03-31
B031AH03L23250AHSAH03L23252016-03-31
B031AH03L25160AHSAH03L25162016-03-31
B031AH03L25250AHSAH03L25252016-03-31
B031AH03L25380AHSAH03L25382016-03-31
B031AH03L27380AHSAH03L27382016-03-31
B031AH03S22190AHSAH03S22192016-03-31
B031AH05M29130AHSAH05M29132016-03-31
B031AH05M2913400AHSAH05M2913402016-03-31
B031AH10M29130AHSAH10M29132016-03-31
B031AH10M2913400AHSAH10M2913402016-03-31

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Primary DI, Brand, Company table
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