FDA.reportPublic FDA data

Tilcare

Primary DI
15060665920497
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
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
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
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
15060665920503Tilcare29 G 12.7 mm insulin syringe 1 ml2020-04-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391530753944FD-1017NS - 1ml PC Syringe - White PlungerDMC MEDICAL LIMITEDFMF2026-06-03
05391530753951FD-1018NS - 1ml PC Syringe - Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-03
05391530754217FD-1078NS 20ml PC Syringe - White Plunger - Saline PrintDMC MEDICAL LIMITEDFMF2026-06-03
05391530754620FD-1048NS 10ml PC Syringe Yellow Plunger LidocaineDMC MEDICAL LIMITEDFMF2026-06-03
05391530754699FD-1075NS 10ml PC Syringe Light Blue Plunger XylocaineDMC MEDICAL LIMITEDFMF2026-06-03
05391530754941FD-1180NS 3ml Nugen Syringe Red PlungeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754965FD-1162NS 10ml Nugen Syringe Red PlungerDMC MEDICAL LIMITEDFMF2026-06-03
05391530753968FD-1019NS - 1ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754088FD-1021NS 3ml PC Syringe White PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754194FD-1034NS 20ml PC Syringe Red PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754224FD-1033NS 20ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754231FD-1092NS 20ml PC Syringe Heparin Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530753456FD-1032NS - 20ml PC Syringe Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753463FD-1031NS - 20ml PC Syringe White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753487FD-1113NS - 10ml PC Syringe Contrast Dark Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753517FD-1051NS - 10ml PC Syringe Purple Plunger - Lidocaine PrintDMC MEDICAL LIMITEDFMF2026-06-01
05391530753524FD-1043NS - 10ml PC Syringe - Contrast - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753531FD-1107NS - 30ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753548FD-1026NS - 10ml PC Syringe - White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753555FD-1158NS - 10ml PC Syringe - Heparin/Saline White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753562FD-1049NS - 10ml PC Syringe - Lidocaine Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753579FD-1029NS - 10ml PC Syringe Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753593FD-1054NS - 10ml PC Syringe - Nitro Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753609FD-1039NS - 10ml PC Syringe - Heparin Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753616FD-1071NS - 10ml PC Syringe - Purple PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753623FD-1028NS - 10ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753647FD-1072NS - 10ml PC Syringe Dark Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753654FD-1030NS - 10ml PC Syringe - Light Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753661FD-1042NS - 10ml PC Syringe - Contrast Print - Light Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753678FD-1044NS - 10ml PC Syringe - Contrast Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01