FDA UDI
In Commercial Distribution
🇺🇸 United States
Envirosystems
DI: 50724995010336
·
Model: PB013
·
STERIS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
Basic Information
- Brand Name
- Envirosystems
- Primary DI
- 50724995010336
- Version / Model
- PB013
- Catalog Number
- PB013
- Company Name
- STERIS CORPORATION
- Labeler DUNS
- 139424188
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2016-09-08
- Public Version
- 5
- Public Version Date
- 2020-10-20
- Public Version Status
- Update
- Public Device Record Key
- 26c80342-b718-4555-a3d8-60ec65ef5952
Device Description
The Envirosystems Ethylene Oxide (EO) Sterilant gas cartridge is a single-unit dose for the Amsco Eagle 3017 EO Sterilizer.
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| FLF | Sterilizer, ethylene-oxide gas | General Hospital | 880.6860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44834 | Ethylene oxide device sterilant | A gaseous substance that includes ethylene oxide (ETO) as its primary agent to completely destroy or eliminate all harmful microorganisms on a medical device (e.g., surgical or dental instrument). The medical device is typically bathed by the substance for a specified period of time in order to achieve sterilization. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 50724995010336 | GS1 | ||||
| Unit of Use | 00724995010331 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 100 | Gram |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature. Do not contaminate water, food, or feed by storage or disposal