FDA.reportPublic FDA data

Tilcare

Primary DI
05060665920490
Brand
Tilcare
Company
TILCO TRADING PTE. LTD.
Model
31 G 8 mm insulin syringe
Device description
31 G 8 mm insulin syringe 1 ml
Published
2020-04-17
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152808000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152808000U&U Insulin Syringe with/without Safety Retractable DeviceU&U Medical Technology Co, Ltd.2016-03-25MEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060665920497PackageGS1100In Commercial Distribution
25060665920494PackageGS12400In Commercial Distribution
05060665920490PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1506066592049715060665920497
2506066592049425060665920494
05060665920490050606659204905060665920490

GMDN Terms#

Term, Definition table
TermDefinition
Medication transfer setA collection of sterile devices and supplies designed to transfer parenteral medications, and sometimes intravenous (IV) fluids, between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it may also be used to reconstitute medication for its preparation and administration. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1Milliliter

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+6531388052customers@tilcare.com

Regulatory Flags#

DUNS number
659506330
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060665920063Tilcare Luer Slip Tip SyringesLUER SLIP TIP LATEX FREE 1ML2019-09-18
05060665920094Tilcare Luer Lock Tip SyringesLUER LOCK TIP LATEX FREE 3ML2019-09-18
05060665920100Tilcare Luer Slip Tip SyringesLUER SLIP TIP LATEX FREE 5ML2019-09-18
05060665920117Tilcare Luer Lock Tip SyringesLUER LOCK TIP LATEX FREE 5 ML2019-09-18
05060665920131Tilcare Luer Slip Tip SyringesLUER SLIP TIP LATEX FREE 10ML2019-09-18
05060665920148Tilcare Luer Lock Tip SyringesLUER LOCK TIP LATEX FREE 10ML2019-09-18
05060665920506Tilcare29 G 12.7 mm insulin syringe 1 ml2020-04-17
05060665920520Tilcare31 G 8 mm insulin syringe 0.3ml2020-04-17
05060665920070Tilcare Luer Lock tip SyringesLUER LOCK TIP LATEX FREE 1ML2019-09-18
05060665920087Tilcare Luer Slip Tip SyringesLUER SLIP TIP LATEX FREE 3ML2019-09-18
05060665920124Tilcare Oral Dispenser with CoverORAL DISPENSER WITH COVER 5ML2019-09-18
05060665920155Tilcare Oral Dispenser with CoverORAL DISPENSER WITH COVER 10ML2019-09-18
05060665920209Tilcare Oral Dispenser with Cover ORAL DISPENSER WITH COVER 30ML2019-09-18
05060665920469Tilcare ORAL DISPENSER WITH COVER 3ML2020-04-17
05060665920452TilcareORAL DISPENSER WITH COVER 1ML2020-04-17
05060665920162Tilcare Oral Dispenser with CoverORAL DISPENSER WITH COVER 20ML2019-09-18
05060665920179Tilcare CATHETER TIP WITH COVER 60ML2019-09-18
15060665920466Tilcare ORAL DISPENSER WITH COVER 3ML2020-04-17
15060665920497Tilcare31 G 8 mm insulin syringe2020-04-17
15060665920503Tilcare29 G 12.7 mm insulin syringe 1 ml2020-04-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850091070372CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070389CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070396CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070402CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070419CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070426CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070433CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
06976523540238Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
06976523540245Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
06976523540252Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
00193982458119INSTAFILLGLOBUS MEDICAL, INC.FMF2026-08-14
00193982458126INSTAFILLGLOBUS MEDICAL, INC.FMF2026-08-14
00193982504403INSTAFILLGLOBUS MEDICAL, INC.FMF2026-08-14
00884450487402Merit Medical®Merit Medical Systems, Inc.FMF2026-08-07
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