Maxi-Pleat

GUDID 25060120952565

GVS FILTER TECHNOLOGY UK LTD

Microbial medical gas filter, non-sterile, single-use
Primary Device ID25060120952565
NIH Device Record Keyd137a2d8-47e8-4a9d-aca8-932a852999f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameMaxi-Pleat
Version Model Number6888/20BAUA001/0001
Company DUNS769934225
Company NameGVS FILTER TECHNOLOGY UK LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS115060120952568 [Primary]
GS125060120952565 [Package]
Contains: 15060120952568
Package: Inner Box [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAHFilter, Bacterial, Breathing-Circuit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

Devices Manufactured by GVS FILTER TECHNOLOGY UK LTD

15060120959710 - Smoke Set2024-08-09 The combination particle and gas filter is used as part of a smoke evacuation system which reduces particulate and odour causing
15060120959772 - Smoke Gas Evacuation Tube Set 2024-08-09 The combination particle and gas filter is used as part of a smoke evacuation system which reduces particulate and odour causing
15060120959727 - Insufflation Set2024-08-08 To be used in conjunction with insufflators for intra-abdominal insufflation. Single use, disposable device.
15060120957747 - HEPA Ventilation Filter2020-07-06
25060120956297 - Multi-Vent2018-12-31
35060120950100 - ECO HMEF2018-07-06
35060120950773 - ECO Maxi Filter2018-07-06
35060120951671 - Spiroguard 2018-07-06

Trademark Results [Maxi-Pleat]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MAXI-PLEAT
MAXI-PLEAT
74224967 1707994 Dead/Cancelled
Air Kontrol, Inc.
1991-11-25

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