| Primary Device ID | B226842142 |
| NIH Device Record Key | 380006c7-78ad-41f6-8bd6-da782a0775d5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sun Medical Inc |
| Version Model Number | 84214 |
| Catalog Number | 84214 |
| Company DUNS | 095223103 |
| Company Name | SUN MEDICAL INC |
| Device Count | 25 |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 9033569000 |
| Spolk@sunmedicalinc.com | |
| Phone | 9033569000 |
| Spolk@sunmedicalinc.com |
| Outer Diameter | 14 Millimeter |
| Outer Diameter | 14 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B226842142 [Primary] |
| HIBCC | B842142 [Unit of Use] |
| HDB | Extractor, Vacuum, Fetal |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-01-23 |
| B226845002 | Aspirator Tubing with Swivel Handle |
| B226845000 | Aspirator Tubing with Swivel Handle |
| B226844002 | Aspirator Tubing with adaptor |
| B226844000 | Aspirator Tubing with Adaptor |
| B226843002 | Disposable Swivel Handle for uses with Aspirator tubing and Cannula |
| B226843000 | Disposable Swivel Handle for use with Aspirator Tubing and Cannula |
| B226842142 | 14mm Curved Cannula |
| B226842140 | 14mm Curved Cannula |
| B226842122 | 12mm Curved Cannula |
| B226842120 | 12mm Curved Canula |
| B226842102 | 10mm Curved Cannula |
| B226842100 | 10mm Curved Cannula |
| B226842082 | 8mm Curved Cannula |
| B226842080 | 8mm Curved Cannula |
| B226841142 | 14mm Straight Cannula |
| B226841140 | 14mm Straight Cannula |
| B226841122 | 12mm Straight Cannula |
| B226841120 | 12mm Straight Cannula |
| B226841102 | 10mm Straight Cannula |
| B226841100 | 10mm Straight Cannula |
| B226841082 | 8mm Straight Cannula |
| B226841080 | 8mm Straight Cannula |
| B22691200000 | Smoke/Fluid evacuator system |
| B22687300001 | Smoke Evacuator Circiut |
| B22687300000 | Smoke Evacuator Circuit |