FDA.reportPublic FDA data

EO Chex 1" Indicator Tape - 36 rolls/case

Primary DI
10818087011089
Brand
EO Chex 1" Indicator Tape - 36 rolls/case
Company
PROPPER MANUFACTURING COMPANY, INC.
Model
26811600
Catalog number
26811600
Device description
EO Chex 1" Indicator Tape - 36 rolls/case
Published
2024-07-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
K240910000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240910000EO Chex Indicator TapePropper Manufacturing Co., Inc.2024-06-12JOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
70818087011081PrimaryGS10
10818087011089Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
7081808701108170818087011081
1081808701108910818087011089

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001483130
Device count
36
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
70818087010756"Propper Verline 1"" Steam Autoclave Tape Mini-Rolls"26814616268146162023-02-23

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Primary DI, Brand, Company table
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