FDA.reportPublic FDA data

Hu-Friedy

Primary DI
10889950002374
Brand
Hu-Friedy
Company
HU-FRIEDY MFG. CO., LLC
Model
IMS-1259
Catalog number
IMS-1259
Device description
IMS Monitor Tape (Prophy)
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K171823000
K890755000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171823000U&U Indicator tape and stripU&U Medical Technology Co, Ltd.2018-02-22JOJ
K890755000SEALING TAPE, STERILIZATION INDICATOR; STEAMSpsmedical Supply Corp.1989-08-07JOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889950002374PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088995000237410889950002374

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging tapeA non-sterile, flexible, band (typically made of paper) coated on one side with a pressure-sensitive adhesive, used to seal packages of instruments, utensils, or medical devices that are wrapped in drapes or sterilization packaging, prior to being sterilized in the hospital or other facility. This device will typically have indicators on its non-adhesive side that darken to indicate that the package has been sterilized. It typically comes in rolls in a variety of widths. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature60 Degrees Fahrenheit85 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
005085972
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889950157623Hu-FriedyI1308CE2LP2026-07-28
10889950157562Hu-FriedyIMN4120C22026-07-13
10889950157579Hu-FriedyIMN4122C22026-07-13
10889950154066PWR AirAPAIRPOL2026-01-14
10889950154080HuFriedyGroupDAPAIRPOL2026-01-14
10889950154103HuFriedyGroupLAPAIRPOL2026-01-14
10889950157517Hu-FriedyIMN4120C2F2026-06-23
10889950157524Hu-FriedyIMN4122C2F2026-06-23
10889950157531Hu-FriedyIMN4128C2F2026-06-23
10889950157326Hu-FriedyIMNO24511C2026-05-26
10889950147020Hu-FriedyDSBH5/662026-04-17
10889950157180Hu-FriedyIM40580-C42026-04-07
10889950157197Hu-FriedyIMN9142HAS2026-04-07
10889950126339Hu-Friedy MFG Co., LLC.CLAWXS2026-04-06
10889950126346Hu-Friedy MFG Co., LLC.CLAWS2026-04-06
10889950126353Hu-Friedy MFG Co., LLC.CLAWM2026-04-06
10889950126360Hu-Friedy MFG Co., LLC.CLAWL2026-04-06
10889950126377Hu-Friedy MFG Co., LLC.CLAWXL2026-04-06
10889950126384Hu-Friedy MFG Co., LLC.CLAWXSX2026-04-06
10889950126391Hu-Friedy MFG Co., LLC.CLAWSX2026-04-06

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