Isofluid™ Earloop Mask

GUDID 00732224004365

Isofluid™ Earloop Mask

CROSSTEX INTERNATIONAL, INC.

Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use
Primary Device ID00732224004365
NIH Device Record Key76b4b2fa-a86a-4951-9259-940e3a935b75
Commercial Distribution StatusIn Commercial Distribution
Brand NameIsofluid™ Earloop Mask
Version Model NumberGCIBL300
Company DUNS057728685
Company NameCROSSTEX INTERNATIONAL, INC.
Device Count300
DM Exempttrue
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-Countertrue

Customer Support Contacts

Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE

Device Identifiers

Device Issuing AgencyDevice ID
GS100732224004365 [Unit of Use]
GS110732224004362 [Primary]

FDA Product Code

FXXMask, surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-08-01
Device Publish Date2020-09-23

On-Brand Devices [Isofluid™ Earloop Mask]

10732224004362Isofluid™ Earloop Mask
00732224004365Isofluid™ Earloop Mask

Trademark Results [Isofluid]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ISOFLUID
ISOFLUID
78958015 not registered Dead/Abandoned
CHEVRON INTELLECTUAL PROPERTY LLC
2006-08-22
ISOFLUID
ISOFLUID
74612781 1975458 Live/Registered
CROSSTEX INTERNATIONAL INC.
1994-12-19

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