FDA UDI
In Commercial Distribution
🇺🇸 United States
ProCure
DI: 10840330705100
·
Model: 1007082
·
Twin Med, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ProCure
- Primary DI
- 10840330705100
- Version / Model
- 1007082
- Catalog Number
- 1007082
- Company Name
- Twin Med, LLC
- Labeler DUNS
- 107071289
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-30
- Public Version
- 2
- Public Version Date
- 2026-04-08
- Public Version Status
- Update
- Public Device Record Key
- 71a9846e-6b8b-4c0f-ade0-d3f55de66a27
Device Description
750cc Drainage bag with Y-Adapter and Hanger. Designed to ensure patients receive mist rather than liquid accumulated in the tubing. Includes hanger and bottom drainage port. Works with 22mm corrugated tubing 50/case.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| BYH | Drain, Tee (Water Trap) | Anesthesiology | 868.5995 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41679 | Breathing circuit condensate trap, single-use | A non-sterile device intended to be integrated within a breathing circuit (e.g., ventilator or respirator breathing circuit) to collect the condensate which accumulates typically during heated humidification. It includes a fluid collection container with input and output connections, and may have an automatic seal to prevent fluid leaks when removed from the circuit; it does not include a moisture filter. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10840330705100 | GS1 | ||||
| Package | 30840330705104 | GS1 | Case | 50 | In Commercial Distribution |
Customer Contacts
- Phone
- 804-776-2873
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 7 | Inch |