FDA.reportPublic FDA data

Propper Steam-Dot Blu Process Indicator

Primary DI
30818087012967
Brand
Propper Steam-Dot Blu Process Indicator
Company
PROPPER MANUFACTURING COMPANY, INC.
Model
36400200
Catalog number
36400200
Device description
"Steam-Dot™ Blu Process Indicator - 1/2"" - 1 box of 1000"
Published
2017-10-16
Public version status
Update
Distribution status
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
K111453000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111453000STEAM DOT BLU PROCESS INDICATORPropper Mfg. Co., Inc.2012-04-05JOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30818087012967PrimaryGS10
10818087012963Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3081808701296730818087012967
1081808701296310818087012963

GMDN Terms#

Term, Definition table
TermDefinition
Chemical/physical sterilization process indicatorA sterilization indicator designed to respond with a characteristic chemical or physical change to one or more of the physical conditions within the sterilizing chamber. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001483130
Device count
1000
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30818087011960Propper Gas-Chex Indicator Strips26900100269001002017-10-04
70818087011623Macintosh #1 Disposable Laryngoscope Blade19924100199241002026-05-15
70818087011630Macintosh #2 Disposable Laryngoscope Blade19924200199242002026-05-15
70818087011647Macintosh #3 Disposable Laryngoscope Blade19924300199243002026-05-15
70818087011814Macintosh #4 Disposable Laryngoscope Blade19924400199244002026-05-15
70818087011821Miller #0 Disposable Laryngoscope Blade19934000199340002026-05-15
70818087012040Miller #2 Disposable Laryngoscope Blade19934200199342002026-05-15
70818087012156Miller #3 Disposable Laryngoscope Blade19934300199343002026-05-15
70818087012163Miller #4 Disposable Laryngoscope Blade19934400199344002026-05-15
70818087013214Miller #1 Disposable Laryngoscope Blade19934100199341002026-05-15
30818087010918"Verline Steam Autoclave Indicator Tape 1/2"" x 14 YD - 24/pack"26814400268144002023-06-16
30818087010932"Verline Steam Autoclave Indicator Tape 3/4"" x 14 YD - 16/pack"26814500268145002023-06-16
30818087010949"Verline Steam Autoclave Indicator Tape 1"" x 14 YD - 12/pack"26814600268146002023-06-16
30818087012271"Propper 9/16"" Steri-Dot Process Indicator"36100100361001002021-09-12
30818087012325"Propper 1"" Steri-Dot Process Indicator"36100200361002002021-09-12
30818087012400"Propper 3/4"" Steam Dot Process Indicator"36400100364001002021-09-12
70818087010343"Propper Verline Indicator Tape 1/2"" x 14 YDS"26824416268244162022-10-20
70818087010367"Propper 3/4"" Steri-Dot Process Indicator Bulk Pack (110 RL/CS)"36100801361008012022-10-28
70818087010732"Propper Verline 1/2"" Steam Autoclave Tape Mini-Rolls"26814416268144162023-02-23
70818087010749"Propper Verline 3/4"" Steam Autoclave Tape Mini-Rolls"26814516268145162023-02-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840456215180JMUJMU DENTAL, INCJOJ2026-06-05
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