FDA UDI
In Commercial Distribution
🇺🇸 United States
Disconnect Wedge
DI: 10641043553404
·
Model: 10-55340
·
MERCURY ENTERPRISES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Disconnect Wedge
- Primary DI
- 10641043553404
- Version / Model
- 10-55340
- Company Name
- MERCURY ENTERPRISES, INC.
- Labeler DUNS
- 032705659
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-25
- Public Version
- 1
- Public Version Date
- 2021-06-02
- Public Version Status
- New
- Public Device Record Key
- 1ab3d895-a4b0-45f4-a443-540548eb2a68
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BYX | Tubing, Pressure And Accessories | Anesthesiology | 868.5860 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44345 | Respiratory connector disconnection wedge | A device designed to disconnect a breathing system connector from its terminal point of attachment, or to disconnect a connector attached to an artificial airway tube [e.g., an endotracheal (ET) tube or tracheostomy tube]. It is a wedge-shaped device with an open-ended slot in the middle, and is intended to be gently pressed onto the connection point to pry the two entities apart. It is typically included in a tracheostomy tube kit. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30641043553408 | GS1 | 50 | In Commercial Distribution | ||
| Primary | 10641043553404 | GS1 |
Customer Contacts
- Phone
- 7275730088
- [email protected]