FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Environ-mate
DI: B325FM991
·
Model: FM99
·
M D Technologies Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
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Basic Information
- Brand Name
- Environ-mate
- Primary DI
- B325FM991
- Version / Model
- FM99
- Catalog Number
- FM99
- Company Name
- M D Technologies Inc.
- Labeler DUNS
- 859679045
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2022-08-05
- Public Version
- 3
- Public Version Date
- 2025-07-31
- Public Version Status
- Update
- Public Device Record Key
- ff5a3f13-9026-4e57-9832-db58fa3e0ce3
- Distribution End Date
- 2025-07-31
Device Description
Filter-Manifold to Collect Fluids from four suction fields and filter non-liquids. Package of 12.
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 | B325FM990 | HIBCC | ||||
| Primary | B325FM991 | HIBCC |
Customer Contacts
- Phone
- 815-624-3010
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 35 – 120 Degrees Fahrenheit