Lune Medical

GUDID 10816415020000

100" IV Administration Set, 15 Micron Screen, Male Luer Lock (2.5 m) Length - Box

DOUGLAS MEDICAL PRODUCTS, INC.

Intravenous administration set Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive

Primary Device ID	10816415020000
NIH Device Record Key	fa93c371-5218-4c96-a691-96ddaa118cdc
Commercial Distribution Status	In Commercial Distribution
Brand Name	Lune Medical
Version Model Number	G410000
Company DUNS	121040922
Company Name	DOUGLAS MEDICAL PRODUCTS, INC.
Device Count	50
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816415020003 [Unit of Use]
GS1	10816415020000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K162951

FDA Product Code

FPA	Set, Administration, Intravascular

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2019-12-11
Device Publish Date	2017-09-15

On-Brand Devices [Lune Medical]

10816415020239	112" IV Administration Set, Back Check Valve, Needleless Connectors(2), 0.22 Micron Filter, Male
10816415020222	106" IV Administration Set, 0.22 Micron Filter, Needleless Connector, Male Luer Lock (2.7 m) Len
10816415020024	112" IV Administration Set, 15 Micron Screen, Back Check Valve, Needleless Connectors(2), Male L
10816415020017	106" IV Administration Set, 15 Micron Screen, Needleless Connector, Male Luer Lock (2.7 m) Lengt
10816415020000	100" IV Administration Set, 15 Micron Screen, Male Luer Lock (2.5 m) Length - Box