| Primary Device ID | B226845000 | 
| NIH Device Record Key | cf53734d-53c8-4ef7-971e-d6a891ae22a8 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Sun Medical Inc | 
| Version Model Number | 84500 | 
| Catalog Number | 84500 | 
| Company DUNS | 095223103 | 
| Company Name | SUN MEDICAL INC | 
| 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 | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Phone | 9033569000 | 
| Spolk@sunmedicalinc.com | |
| Phone | 9033569000 | 
| Spolk@sunmedicalinc.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| HIBCC | B226845000 [Primary] | 
| 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 |