FDA UDI
In Commercial Distribution
🇺🇸 United States
Propper Duo-Record Steam & Ethylene Oxide Record Keeping Cards
DI: 30818087012011
·
Model: 26905100
·
PROPPER MANUFACTURING COMPANY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1000
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Basic Information
- Brand Name
- Propper Duo-Record Steam & Ethylene Oxide Record Keeping Cards
- Primary DI
- 30818087012011
- Version / Model
- 26905100
- Catalog Number
- 26905100
- Company Name
- PROPPER MANUFACTURING COMPANY, INC.
- Labeler DUNS
- 001483130
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1000
- Record Status
- Published
- Publish Date
- 2017-10-17
- Public Version
- 4
- Public Version Date
- 2025-02-21
- Public Version Status
- Update
- Public Device Record Key
- d9d80399-36cb-479d-af79-9c9fb629f125
Device Description
Duo-Record® Steam & Ethylene Oxide Record Keeping Cards - 1 Box of 1000 Cards
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | General Hospital | 880.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35362 | Chemical/physical sterilization process indicator | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 30818087012011 | GS1 | ||||
| Unit of Use | 10818087012017 | GS1 |