| Primary Device ID | 07393507313012 | 
| NIH Device Record Key | 5e2bf712-9aa6-4f3f-b3e5-f7a478b8e34b | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Hygovac | 
| Version Model Number | Hygovac | 
| Catalog Number | V100 | 
| Company DUNS | 354287922 | 
| Company Name | J.H. Orsing AB | 
| Device Count | 100 | 
| 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 | true | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 07393507311018 [Unit of Use] | 
| GS1 | 07393507312015 [Primary] | 
| GS1 | 07393507313012 [Package] Contains: 07393507312015 Package: Bag [10 Units] In Commercial Distribution | 
| GS1 | 07393507313029 [Package] Contains: 07393507312015 Package: [28 Units] In Commercial Distribution | 
| EHZ | Evacuator, Oral Cavity | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2022-12-14 | 
| Device Publish Date | 2022-12-06 | 
| 07393507113131 - Hygoformic Bio | 2022-12-14 Saliva ejector | 
| 07393507111113 - Hygoformic Comfort Lime Green | 2022-12-14 Saliva ejector | 
| 07393507111076 - Hygoformic Bio | 2022-12-14 Saliva ejector | 
| 07393507121013 - Hygoformic L | 2022-12-14 Saliva ejector | 
| 07393507313012 - Hygovac | 2022-12-14Aspirator tubes | 
| 07393507313012 - Hygovac | 2022-12-14 Aspirator tubes | 
| 07393507313036 - Hygovac Blue | 2022-12-14 Aspirator tubes | 
| 07393507313043 - Hygovac Green | 2022-12-14 Aspirator tubes | 
| 07393507313050 - Hygovac Bio Short | 2022-12-14 Aspirator tubes | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  HYGOVAC  74052256  1663340 Live/Registered | J. H. ORSING AB 1990-04-23 |