FDA.reportPublic FDA data

VH202 INDICATOR STRIP RED

Primary DI
10732224710621
Brand
VH202 INDICATOR STRIP RED
Company
CROSSTEX INTERNATIONAL, INC.
Model
GPS-250R
Catalog number
GPS-250R
Device description
ISO 11140-1 Type 1, 4 in (10 cm)
Published
2016-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOJIndicator, physical/chemical sterilization process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140566000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140566000SPSMEDICAL VH2O2 INDICATOR STRIPS, INDICATOR LABELS, INDICATOR TAPECrosstex International2014-11-24JOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10732224710621PrimaryGS10
00732224710624Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1073222471062110732224710621
00732224710624007322247106247322247106240732224710624

GMDN Terms#

Term, Definition table
TermDefinition
Chemical/physical sterilization process indicatorA sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Controlled room temperature per USP
Special Storage Condition, Specify00Keep away from sunlight
Storage Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(585)359-0130info@spsmedical.com
+1(585)359-0130rcelestin@crosstex.com
+1(800)483-7433care@hu-friedy.com

Regulatory Flags#

DUNS number
057728685
Device count
250
DM exempt
true
Lot or batch
true
Expiration date on label
true

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