FDA UDI
In Commercial Distribution
🇺🇸 United States
TUBE MANAGEMENT CLIP SYSTEM
DI: 05030267092291
·
Model: 2316000
·
Intersurgical Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- TUBE MANAGEMENT CLIP SYSTEM
- Primary DI
- 05030267092291
- Version / Model
- 2316000
- Company Name
- Intersurgical Incorporated
- Labeler DUNS
- 785952607
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-14
- Public Version
- 2
- Public Version Date
- 2022-02-07
- Public Version Status
- Update
- Public Device Record Key
- db1aac18-0d78-441e-9435-0a97b9929d50
Device Description
TUBE MANAGEMENT CLIP SYSTEM
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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
- 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 |
|---|---|---|---|---|
| BZA | Connector, Airway (Extension) | Anesthesiology | 868.5810 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37041 | Breathing circuit tube holder | A device designed primarily to hold the breathing circuit tubing that carries gases from a ventilator and/or anaesthesia system to and from the patient. It is typically fixed to the ventilator/anaesthesia system, but can also be fixed to the patient's bed or medical device service rails (e.g., a wall rail). It is made of metal and plastic materials with adjustable jointed sections. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05030267092307 | GS1 | 12 | In Commercial Distribution | ||
| Primary | 05030267092291 | GS1 | ||||
| Package | 05030267092314 | GS1 | 48 | In Commercial Distribution |
Customer Contacts
- Phone
- 3154512900
- [email protected]