FDA.reportPublic FDA data

AQUILAVIE

Primary DI
20810118890257
Brand
AQUILAVIE
Company
Ahc Americas LLC
Model
J10385
Catalog number
J10385
Device description
Insulin Pen Needle, 32G 5/32"/ (0.23mm * 4mm), 100pcs/box, 12boxes/case, 4cases/carton
Published
2023-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
20810118890257PackageGS112Not in Commercial Distribution
30810118890254PackageGS14Not in Commercial Distribution
10810118890250PrimaryGS10
00810118890253Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081011889025720810118890257
3081011889025430810118890254
1081011889025010810118890250
00810118890253008101188902538101188902530810118890253

GMDN Terms#

Term, Definition table
TermDefinition
Autoinjector needleA device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118840015
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
10810118890014AQUILAVIEJ10049J100492023-04-27
10810118890045AQUILAVIEJ10050J100502023-04-27
10810118890076AQUILAVIEJ10051J100512023-04-27
10810118890106AQUILAVIEJ10052J100522023-04-27
10810118890137AQUILAVIEJ10449J104492023-04-27
10810118890168AQUILAVIEJ10450J104502023-04-27
10810118890199AQUILAVIEJ10451J104512023-04-27
10810118890229AQUILAVIEJ10452J104522023-04-27
10810118890434AQUILAVIEJ10459J104592023-04-27
10810118890465AQUILAVIEJ10460J104602023-04-27
10810118890496AQUILAVIEJ10476J104762023-04-27
10810118890526AQUILAVIEJ10030J100302023-04-27
10810118890557AQUILAVIEJ10032J100322023-04-27
10810118890588AQUILAVIEJ10047J100472023-04-27
00810118890017AQUILAVIEJ10049J100492023-04-27
20810118890042AQUILAVIEJ10050J100502023-04-27
20810118890073AQUILAVIEJ10051J100512023-04-27
20810118890103AQUILAVIEJ10052J100522023-04-27
00810118890130AQUILAVIEJ10449J104492023-04-27
20810118890165AQUILAVIEJ10450J104502023-04-27

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10801902215175ARROWTELEFLEX INCORPORATEDFMI2026-07-29
10801902215182ARROWTELEFLEX INCORPORATEDFMI2026-07-29
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20192253037200MonojectCardinal Health 200, LLCFMI2026-07-09
20192253037255MonojectCardinal Health 200, LLCFMI2026-07-09