FDA UDI
In Commercial Distribution
🇺🇸 United States
Environ-mate
DI: B325PT20C101
·
Model: PT20C-10
·
M D Technologies Inc.
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
10
Basic Information
- Brand Name
- Environ-mate
- Primary DI
- B325PT20C101
- Version / Model
- PT20C-10
- Catalog Number
- PT20C10
- Company Name
- M D Technologies Inc.
- Labeler DUNS
- 859679045
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2022-08-05
- Public Version
- 2
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- 15b3f3a2-364e-4ee7-8d22-e5b59a4b46ab
- Distribution End Date
- 2025-07-31
Device Description
Polyp Trap with screw top, fine-mesh screen and tube with connector.. Package of 10.
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BYZ | Trap, Sterile Specimen | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34858 | Surgical suction system collection container, single-use | A sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., tissue or polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | B325PT20C100 | HIBCC | ||||
| Primary | B325PT20C101 | HIBCC | ||||
| Package | B325PT20C252 | HIBCC | Box | 25 | In Commercial Distribution | 2025-07-31 |
| Package | B325PT20C503 | HIBCC | Box | 50 | In Commercial Distribution | 2025-07-31 |
| Package | B325PT20C1004 | HIBCC | Box | 100 | In Commercial Distribution | 2025-07-31 |
Customer Contacts
- Phone
- 815-624-3010
- [email protected]