FDA.reportPublic FDA data

Getinge Assure Green Tape 3/4 IN

Primary DI
00814434020424
Brand
Getinge Assure Green Tape 3/4 IN
Company
STERITEC PRODUCT MFG. CO., INC.
Model
61301606668
Catalog number
61301606668
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K122555000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122555000STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPESteritec Products Mfg Co, Inc.2012-12-12JOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814434021162PackageGS112Not in Commercial Distribution
00814434021179PackageGS14Not in Commercial Distribution
10814434020421PackageGS148Not in Commercial Distribution
00814434020424PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814434021162008144340211628144340211620814434021162
00814434021179008144340211798144340211790814434021179
1081443402042110814434020421
00814434020424008144340204248144340204240814434020424

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 (non-electrical) 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
Storage Environment Humidity10 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius38 Degrees Celsius

Regulatory Flags#

DUNS number
622223196
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814434021230Getinge Assured MI Steam Migrating Integrator Strip613016068252020-07-17
00814434020264Getinge Assured Mini Bowie-Dick Test Pack61301606667613016066672016-09-23
00814434020172"SteriTec 3/4"" Green Tape"CI 159/.75, CI 165/.75CI 159/.75, CI 165/.752016-09-23
00814434020448Getinge Assure Green Tape 1 IN61301606669613016066692016-09-23
00814434020004SteriTec Cross-Checks DCI 105CI 1052016-09-23
00814434020011SteriTec Steri-Pak LF Bowie-Dick Test PackBD 111BD 1112016-09-23
00814434020028SteriTec Green Card Bowie-Dick TestBD 115BD 115, BD 115/1202016-09-23
00814434020066SteriTec IntegraphCI 101CI 101, CI 101/BR, CI 101/ITL2016-09-23
00814434020073SteriTec Cross-Checks EOCI 106CI 106, CI 106/ITL2016-09-23
00814434020080SteriTec Cross-Checks CI 107/USCI 107/US2016-09-23
00814434020097SteriTec Cross-Checks SCI 134/USCI 134/US2016-09-23
00814434020110SteriTec Sterilization TapeCI 122/.5, CI 164/.5CI 122/.5, CI 164/.52016-09-23
00814434020127SteriTec Sterilization TapeCI 122/.75, CI 164/.75CI 122/.75, CI 164/.752016-09-23
00814434020134SteriTec Sterilization TapeCI 122/1, CI 164/1CI 122/1, CI 164/12016-09-23
00814434020141SteriTec Sterilization Tape - BlueCI 123/1CI 123/12016-09-23
00814434020196SteriTec Steam Integrator X 2CI 143CI 1432016-09-23
00814434020202SteriTec Emu-Graph 4CI 144CI 1442016-09-23
00814434020219SteriTec Instant Readout Chemical Integrator Challenge PackLT 101LT 1012016-09-23
00814434020226SteriTec Chemical Indicator Test Pack for Extended Timing CyclesLT 105LT 1052016-09-23
00814434020233SteriTec Instant Readout Class 6 Chemical Emulator Challenge PackLT 108LT 1082016-09-23

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