FDA UDI
In Commercial Distribution
🇺🇸 United States
PASSPORT PLUS MAIL-IN SYSTEM
DI: 10732224720798
·
Model: PP-012
·
SPS Medical Supply Corp.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
12
Basic Information
- Brand Name
- PASSPORT PLUS MAIL-IN SYSTEM
- Primary DI
- 10732224720798
- Version / Model
- PP-012
- Catalog Number
- PP-012
- Company Name
- SPS Medical Supply Corp.
- Labeler DUNS
- 194877072
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2016-11-15
- Public Version
- 4
- Public Version Date
- 2024-01-18
- Public Version Status
- Update
- Public Device Record Key
- 287ed84e-27d7-4410-ab4c-ed4897ec4ba2
Device Description
Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and EO Gas processes.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| FRC | Indicator, biological sterilization process | General Hospital | 880.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13732 | Biological sterilization indicator | A sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50732224720796 | GS1 | box | 10 | In Commercial Distribution | |
| Primary | 10732224720798 | GS1 | ||||
| Unit of Use | 00732224720791 | GS1 |
Customer Contacts
- Phone
- 1-585-359-0130
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Controlled room temperature per USP
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius