FDA.reportPublic FDA data

Tilcare

Primary DI
15060665920503
Brand
Tilcare
Company
TILCO TRADING PTE. LTD.
Model
29 G 12.7 mm insulin syringe 1 ml
Device description
29 G 12.7 mm insulin syringe 1 ML
Published
2020-04-17
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

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
15060665920503PackageGS1100In Commercial Distribution
25060665920500PackageGS12000In Commercial Distribution
05060665920506PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1506066592050315060665920503
2506066592050025060665920500
05060665920506050606659205065060665920506

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
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
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
05060665920490Tilcare31 G 8 mm insulin syringe2020-04-17
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850091070242CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
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