FDA.reportPublic FDA data

AQUILAVIE

Primary DI
20810118890318
Brand
AQUILAVIE
Company
Ahc Americas LLC
Model
J10341
Catalog number
J10341
Device description
Disposable Insulin Syringe, U-100, 0.5mL 30G 5/16"/0.5CC (0.31mm 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
OTC
false
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
20810118890318PackageGS110Not in Commercial Distribution
30810118890315PackageGS15Not in Commercial Distribution
40810118890312PackageGS16Not in Commercial Distribution
10810118890311PrimaryGS10
00810118890314Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081011889031820810118890318
3081011889031530810118890315
4081011889031240810118890312
1081011889031110810118890311
00810118890314008101188903148101188903140810118890314

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118840015
Device count
10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800045103061Feel Ject(FIS-054, U-100, 1.0cc, 31G x 6mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105164Feel Ject(FIS-202, U-100, 0.3 cc, 29G x 12.7mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105256Feel Ject(FIS-205, U-100, 0.3 cc, 31G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105492Feel Ject(FIS-213, U-100, 1.0cc, 31G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105614Feel Ject(FIS-217, U-100, 0.5 cc, 31G x 6mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
00810131885045ION Non CervicalSurgentec, LLCFMF2026-07-28
00884450486955Merit Medical®Merit Medical Systems, Inc.FMF2026-07-25
10816336022275NC600300-ENFNEOCHILD, LLCFMF2026-07-23
10816336022282NC602000-ENFNEOCHILD, LLCFMF2026-07-23
10816336022442NC600100-ENFNEOCHILD, LLCFMF2026-07-23
00884450492888Merit Medical®Merit Medical Systems, Inc.FMF2026-07-22
10383017593015Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593213Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593411Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593510Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593718Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844612Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844711Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844919Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
18257200121076O-GENESISOrthofix US LLCFMF2026-07-17
18257200121083O-GENESISOrthofix US LLCFMF2026-07-17
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