FDA.reportPublic FDA data

Aimsco

Primary DI
DHT16312
Brand
Aimsco
Company
DELTA HI TECH INC
Model
631
Published
2017-01-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
DHT16312PrimaryHIBCC0
DHT16310Unit of UseHIBCC0

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
Ethylene Oxide

Regulatory Flags#

DUNS number
008597056
Device count
100
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
DHT15021Aimsco5022017-01-06
DHT15031Aimsco5032017-01-06
DHT15261Aimsco5262017-01-06
DHT15271Aimsco5272017-01-06
DHT15281Aimsco5282017-01-06
DHT15291Aimsco5292017-01-06
DHT16181Aimsco6182017-01-06
DHT16201Aimsco6202017-01-06
DHT16262Aimsco6262022-05-04
DHT16322Aimsco6322017-01-06
DHT16252Aimsco6252022-05-04
DHT16332Aimsco6332022-05-04
DHT17221Aimsco7222017-01-06
DHT17401Aimsco7402017-01-06
DHT17421Aimsco7422017-01-06
DHT17441Aimsco7442017-01-06
DHT16222Aimsco6222017-01-06
DHT16302Aimsco6302017-01-06
DHT16250Aimsco6252022-05-04
DHT16260Aimsco6262022-05-04

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Primary DI, Brand, Company table
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