FDA UDI
In Commercial Distribution
🇺🇸 United States
BE 122-2TSB - 4" Flexible Support Arm Double Tubing Clamp
DI: M996BE1222TSB0
·
Model: BE 122-2TSB
·
INSTRUMENTATION INDUSTRIES, INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BE 122-2TSB - 4" Flexible Support Arm Double Tubing Clamp
- Primary DI
- M996BE1222TSB0
- Version / Model
- BE 122-2TSB
- Catalog Number
- BE 122-2TSB
- Company Name
- INSTRUMENTATION INDUSTRIES, INCORPORATED
- Labeler DUNS
- 053146767
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-31
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- e84ae27d-dc1b-4d6f-bc85-e31b486f6c79
Device Description
BE 122-2TSB - 4" Flexible Support Arm Double Tubing Clamp holds two ventilator tubes in place when attached to an III "Flexible Support Arm". Made of polypropylene and anodized aluminum with phenolic ball knob. Made in the USA.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| JAY | Support, Breathing Tube | Anesthesiology | 868.5280 | 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 |
|---|---|---|---|---|---|---|
| Primary | M996BE1222TSB0 | HIBCC |
Customer Contacts
- Phone
- 412-854-1133
- [email protected]