| Primary Device ID | 00310819000482 |
| NIH Device Record Key | ac1962dc-6cb6-4132-99f0-f4b2bb39bf07 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PDI® Lubricating Jelly II |
| Version Model Number | T00137 |
| Catalog Number | T00137 |
| Company DUNS | 800777117 |
| Company Name | PROFESSIONAL DISPOSABLES INTERNATIONAL, 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 | false |
| 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 |
| Weight | 2.7 Gram |
| Weight | 2.7 Gram |
| Weight | 2.7 Gram |
| Weight | 2.7 Gram |
| Weight | 2.7 Gram |
| Weight | 2.7 Gram |
| Weight | 2.7 Gram |
| Weight | 2.7 Gram |
| Weight | 2.7 Gram |
| Weight | 2.7 Gram |
| Weight | 2.7 Gram |
| Weight | 2.7 Gram |
| Weight | 2.7 Gram |
| Weight | 2.7 Gram |
| Weight | 2.7 Gram |
| Weight | 2.7 Gram |
| Weight | 2.7 Gram |
| Weight | 2.7 Gram |
| Weight | 2.7 Gram |
| Weight | 2.7 Gram |
| Weight | 2.7 Gram |
| Weight | 2.7 Gram |
| Weight | 2.7 Gram |
| Weight | 2.7 Gram |
| Weight | 2.7 Gram |
| Weight | 2.7 Gram |
| Weight | 2.7 Gram |
| Weight | 2.7 Gram |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00310819000482 [Primary] |
| GS1 | 10310819000489 [Package] Package: Box [144 Units] In Commercial Distribution |
| KMJ | Lubricant, Patient |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-19 |
| Device Publish Date | 2020-10-09 |
| 00310819000499 | Lubricating jelly to lubricate the body orifices to facilitate the entry of medical and therapeu |
| 00310819000482 | Lubricating jelly to lubricate the body orifices to facilitate the entry of medical and therapeu |