FDA.reportPublic FDA data

Steam Indicator Tape

Primary DI
00732224004167
Brand
Steam Indicator Tape
Company
CROSSTEX INTERNATIONAL, INC.
Model
BTLF18MM
Catalog number
BTLF18MM
Device description
Lead Free, Blue, 0.75 in x 60 yd (18 mm x 55 mm)
Published
2019-09-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K191741000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191741000Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization TapeIntertape Polymer, Inc.2019-08-02JOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50732224004162PackageGS124In Commercial Distribution
00732224004167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5073222400416250732224004162
00732224004167007322240041677322240041670732224004167

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity050 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(800)483-7433care@hu-friedy.com

Regulatory Flags#

DUNS number
057728685
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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10732224003556Advantage Plus Cotton Tipped ApplicatorsH6AC2022-08-19
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50732224001291Polyback™ TowelsWPXFP2022-10-31
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50732224002359Econoback™ TowelsWEXFP2022-10-31
50732224002366Econoback™ TowelsWEXTB2022-10-31
50732224003936Non-Woven Headrest coversL3CB2022-09-29
50732224004841Professional Regular TowelsWTXFPWTXFP2023-07-17
30732224001136Self-Sealing Sterilization BagOCS2022-05-03
50732224005206Premium Non-Woven SpongesENCNW4KENCNW4K2025-10-23
50732224001086Ultra Gauze Non-Woven SpongesENCNWUBENCNWUB2025-10-23
10732224001088Ultra Gauze Non-Woven SpongesENCNWUBENCNWUB2022-08-25
10732224005208Premium Non-Woven SpongesENCNW4KENCNW4K2023-07-17
50732224000140Sani Vac Evacuation System CleanerJVACSAMPLESJVACSAMPLES2022-08-19
10732224110568Duo-Check Self-Sealing Sterilization PouchesSCM2025-07-24
10732224000050Crosstex InternationalSCMSCM2016-11-11

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