FDA.reportPublic FDA data

AQUILAVIE

Primary DI
10810118890397
Brand
AQUILAVIE
Company
Ahc Americas LLC
Model
J10355
Catalog number
J10355
Device description
"Disposable Insulin Syringe, U-100, 1mL 31G 5/16""/1CC (0.25mm x 8mm),10pcs/bag, 10bags/box, 5boxes/case, 6cases/carton"
Published
2023-04-20
Public version status
New
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
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20810118890394PackageGS110In Commercial Distribution
30810118890391PackageGS15In Commercial Distribution
40810118890398PackageGS16In Commercial Distribution
10810118890397PrimaryGS10
00810118890390Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081011889039420810118890394
3081011889039130810118890391
4081011889039840810118890398
1081011889039710810118890397
00810118890390008101188903908101188903900810118890390

GMDN Terms#

Term, Definition table
TermDefinition
Insulin syringe/needle, safetyA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; it includes an attached needle with a safety mechanism, such as cylinder/flap shielding or retraction into the barrel or sleeve after use, providing protection against needle sticks and rendering the device unusable. The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties (internally precoated with compatible substances) allowing smooth plunger movement. It can be used by healthcare personnel or patients.. This is a single-use device.

Regulatory Flags#

DUNS number
118840015
Device count
10
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391530753944Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753951Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754217Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754620Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754699Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754941NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754965NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753968Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754088Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754194Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754224Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754231Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530753456Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753463Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753487Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753517Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753524Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753531Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753548Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753555Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753562Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753579Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753593Polycarbonate syringe -DMC MEDICAL LIMITEDFMF2026-06-01
05391530753609Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753616Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753623Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753647Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753654Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753661Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753678Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01