PNEUVIEW XE 9660-XENS

GUDID 00852588007052

LAPAROSCOPIC SMOKE ELIMINATION DEVICE

LEXION MEDICAL, LLC

Laparoscopic plume filter Laparoscopic plume filter Laparoscopic plume filter Laparoscopic plume filter Laparoscopic plume filter Laparoscopic plume filter Laparoscopic plume filter Laparoscopic plume filter Laparoscopic plume filter Laparoscopic plume filter

Primary Device ID	00852588007052
NIH Device Record Key	6a28dcec-891f-4f8b-9d84-dce295a8d921
Commercial Distribution Status	In Commercial Distribution
Brand Name	PNEUVIEW XE
Version Model Number	9660-XENS
Catalog Number	9660-XENS
Company DUNS	848693730
Company Name	LEXION MEDICAL, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	true
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	true
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	00852588007052 [Primary]

FDA Product Code

FCZ	Tube, Smoke Removal, Endoscopic

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00852588007052]

Ethylene Oxide

[00852588007052]

Ethylene Oxide

[00852588007052]

Ethylene Oxide

[00852588007052]

Ethylene Oxide

[00852588007052]

Ethylene Oxide

[00852588007052]

Ethylene Oxide

[00852588007052]

Ethylene Oxide

[00852588007052]

Ethylene Oxide

[00852588007052]

Ethylene Oxide

[00852588007052]

Ethylene Oxide

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2018-03-29
Device Publish Date	2017-02-15

On-Brand Devices [PNEUVIEW XE]

00852588007052	LAPAROSCOPIC SMOKE ELIMINATION DEVICE
00852588007045	LAPAROSCOPIC SMOKE ELIMINATION DEVICE