AccessGUDID - DEVICE: Tilcare Luer Lock Tip Syringes (05060665920148)

GUDID

Device Identifier (DI) Information

Brand Name: Tilcare Luer Lock Tip Syringes
Version or Model: LUER LOCK TIP LATEX FREE 10ML
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TILCO TRADING PTE. LTD.

Primary DI Number: 05060665920148
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 659506330 *Terms of Use

Device Description: Luer Lock Tip Syringes 10 ml

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
41222	Medication transfer set	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMF	Syringe, Piston

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 10 Milliliter

Device Record Status

Public Device Record Key: 6c055d99-8335-4b9e-a7a2-9d9aedef1f6b
Public Version Date: April 06, 2020
Public Version Number: 3
DI Record Publish Date: September 18, 2019