SealFlex

GUDID 20841470108186

ENGINEERED MEDICAL SYSTEMS INC

CPAP/BPAP face mask, single-use
Primary Device ID20841470108186
NIH Device Record Key2d359cf8-4149-4c86-a537-8f9d373123b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameSealFlex
Version Model Number4-005520-00
Company DUNS154502934
Company NameENGINEERED MEDICAL SYSTEMS INC
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100841470108182 [Primary]
GS110841470108189 [Package]
Contains: 00841470108182
Package: [10 Units]
In Commercial Distribution
GS120841470108186 [Package]
Contains: 00841470108182
Package: [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZDVentilator, Non-Continuous (Respirator)

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 Date2017-12-22

On-Brand Devices [SealFlex]

208414701081864-005520-00
308414701081764-005521-00

Trademark Results [SealFlex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SEALFLEX
SEALFLEX
78773999 3309283 Dead/Cancelled
Viskase Companies, Inc.
2005-12-15
SEALFLEX
SEALFLEX
77946219 4204021 Dead/Cancelled
LAYFIELD GROUP LIMITED
2010-02-26
SEALFLEX
SEALFLEX
73708547 not registered Dead/Abandoned
ENGINEERED MEDICAL SYSTEMS, INC.
1988-02-01
SEALFLEX
SEALFLEX
73313470 not registered Dead/Abandoned
ENVIRON PRODUCTS INC.
1981-07-15

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