FDA UDI
In Commercial Distribution
🇺🇸 United States
KC 5 Pressure Adapter
DI: M996KC50
·
Model: KC 5
·
INSTRUMENTATION INDUSTRIES, INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- KC 5 Pressure Adapter
- Primary DI
- M996KC50
- Version / Model
- KC 5
- Catalog Number
- KC 5
- Company Name
- INSTRUMENTATION INDUSTRIES, INCORPORATED
- Labeler DUNS
- 053146767
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-17
- Public Version
- 1
- Public Version Date
- 2018-10-18
- Public Version Status
- New
- Public Device Record Key
- 9d30be0e-9816-4583-b043-af2537796304
Device Description
The KC 5 Pressure Adapter: Dimensions - Luer Lock port x 15mm I.D./22mm O.D. x 15mm O/D.
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
- Yes
- Sterilization Methods
- Ethylene Oxide, High-level Disinfectant
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 |
|---|---|---|---|---|
| 61621 | Breathing circuit pressure detection port plug | A non-sterile device designed to seal the port of a breathing circuit pressure detection adaptor/connector (e.g., Y-piece) when the port is not needed for pressure monitoring. It is typically a small Luer cap made of plastic (e.g., polysulphone). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M996KC50 | HIBCC |
Customer Contacts
- Phone
- 412-854-1133
- [email protected]