AccessGUDID - DEVICE: Medefil Heparin Lock Flush Syringe, 1 Unit/mL (30364253444358)

GUDID

Device Identifier (DI) Information

Brand Name: Medefil Heparin Lock Flush Syringe, 1 Unit/mL
Version or Model: 5mL in 12mL Syringe
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MIH-4435
Company Name: MEDEFIL, INC.

Primary DI Number: 30364253444358
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 60
Labeler D-U-N-S® Number*: 016448669 *Terms of Use

Device Description: Medefil Heparin Lock Flush Syringe, 1 Unit/mL, 5mL in 12mL Syringe, Does not contain natural rubber latex or preservatives. Contents and its pathway are sterile. Single use.

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):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
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?
47132	Vascular catheter/cannula flush solution, anticoagulant, non-antimicrobial	A solution which contains a low dose (e.g., 10 i.u. ) of an anticoagulant agent(s) [typically heparin] intended to flush the lumen of an in situ intravenous access device (IVAD), typically a peripheral intravenous cannula or central venous catheter, to maintain patency; it does not include an antimicrobial agent. Also known as lock solution, the device is available in a small container (e.g., bottle) or prefilled syringe. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NZW	Heparin, Vascular Access Flush

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092491	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a9b25978-54a1-42dd-afe9-5d4bd6f272dc
Public Version Date: July 07, 2020
Public Version Number: 5
DI Record Publish Date: December 14, 2016