FDA UDI
In Commercial Distribution
🇺🇸 United States
KC 10 Tubing Separator
DI: M996KC100
·
Model: KC 10
·
INSTRUMENTATION INDUSTRIES, INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- KC 10 Tubing Separator
- Primary DI
- M996KC100
- Version / Model
- KC 10
- Catalog Number
- KC 10
- Company Name
- INSTRUMENTATION INDUSTRIES, INCORPORATED
- Labeler DUNS
- 053146767
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-31
- Public Version
- 1
- Public Version Date
- 2019-06-10
- Public Version Status
- New
- Public Device Record Key
- 1d4b435f-6bfe-401b-bbe5-03051341d80f
Device Description
KC 10 Tubing Separator separates large bore tubing from small bore tubing. Made of silicone rubber. Reusable. Made in the USA.
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
- 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 |
|---|---|---|---|---|
| BZO | Set, Tubing And Support, Ventilator (W Harness) | Anesthesiology | 868.5975 | 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 | M996KC106 | HIBCC | Ziplock bag | 100 | In Commercial Distribution | |
| Primary | M996KC100 | HIBCC | ||||
| Package | M996KC102 | HIBCC | Ziplock bag | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 412-854-1133
- [email protected]