FDA UDI
Not in Commercial Distribution
🇺🇸 United States
VERIFY
DI: 00724995002534
·
Model: PCC070
·
STERIS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- VERIFY
- Primary DI
- 00724995002534
- Version / Model
- PCC070
- Catalog Number
- PCC070
- Company Name
- STERIS CORPORATION
- Labeler DUNS
- 961394798
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-07
- Public Version
- 6
- Public Version Date
- 2020-02-07
- Public Version Status
- Update
- Public Device Record Key
- f977139f-7942-4f39-aa35-c04137888fc3
- Distribution End Date
- 2020-02-07
Device Description
The VERIFY VH202 Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change. It can be changed in all V-PRO Low Temperature Sterilization Systems and Sterrad 100S, NX and 100NX Sterilizers.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| JOJ | Indicator, physical/chemical sterilization process | General Hospital | 880.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44427 | Sterilization packaging tape | A non-sterile, flexible, band (typically made of paper) coated on one side with a pressure-sensitive adhesive, used to seal packages of instruments, utensils, or medical devices that are wrapped in drapes or sterilization packaging, prior to being sterilized in the hospital or other facility. This device will typically have indicators on its non-adhesive side that darken to indicate that the package has been sterilized. It typically comes in rolls in a variety of widths. After application, this device cannot be reused. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00724995002534 | GS1 | ||||
| Package | 50724995002539 | GS1 | Case | 6 | Not in Commercial Distribution | 2020-02-07 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 60 | Yard |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry and away from sunlight. Do not store near heat, moisture, oxidizing agents, acids/alkalis, or cleaning/disinfecting agents.
- Type
- Storage Environment Temperature
- Temperature Range
- 16 – 24 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 60 Percent (%) Relative Humidity