| Primary Device ID | M996KC01830 |
| NIH Device Record Key | d587143e-d81c-4179-abea-c0aa009b6e8e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KC 018-3 22mm ID Ventilator Tubing with Integral Cuffs |
| Version Model Number | KC 018-3 |
| Company DUNS | 053146767 |
| Company Name | INSTRUMENTATION INDUSTRIES, INCORPORATED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 412-854-1133 |
| raqa@iiimedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M996KC01830 [Primary] |
| BZO | Set, Tubing And Support, Ventilator (W Harness) |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M996KC01830]
Ethylene Oxide;Radiation Sterilization;Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-12-11 |
| Device Publish Date | 2017-04-14 |
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