| Primary Device ID | 07393507591014 |
| NIH Device Record Key | 080d531e-3ce8-4cfa-97c1-6960e0ea3a1a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Shield refill, Careshield |
| Version Model Number | Careshield |
| Catalog Number | SL100 |
| 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 | 07393507591014 [Unit of Use] |
| GS1 | 07393507592011 [Primary] |
| 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 |
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| 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 | 2022-12-14 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 |