| Primary Device ID | 10667560011005 |
| NIH Device Record Key | 2237b0a6-3b10-4505-8ae0-bdd955adcf75 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cura Heat |
| Version Model Number | 667560011008 |
| Company DUNS | 618672760 |
| Company Name | KOBAYASHI CONSUMER PRODUCTS, LLC |
| Device Count | 3 |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | +1(800)432-6329 |
| kcpinfo@kobayashi.com | |
| Phone | +1(800)432-6329 |
| kcpinfo@kobayashi.com | |
| Phone | +1(800)432-6329 |
| kcpinfo@kobayashi.com | |
| Phone | +1(800)432-6329 |
| kcpinfo@kobayashi.com | |
| Phone | +1(800)432-6329 |
| kcpinfo@kobayashi.com | |
| Phone | +1(800)432-6329 |
| kcpinfo@kobayashi.com | |
| Phone | +1(800)432-6329 |
| kcpinfo@kobayashi.com | |
| Phone | +1(800)432-6329 |
| kcpinfo@kobayashi.com | |
| Phone | +1(800)432-6329 |
| kcpinfo@kobayashi.com | |
| Phone | +1(800)432-6329 |
| kcpinfo@kobayashi.com | |
| Phone | +1(800)432-6329 |
| kcpinfo@kobayashi.com | |
| Phone | +1(800)432-6329 |
| kcpinfo@kobayashi.com | |
| Phone | +1(800)432-6329 |
| kcpinfo@kobayashi.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00667560011008 [Primary] |
| GS1 | 10667560011005 [Package] Contains: 00667560011008 Package: box [24 Units] In Commercial Distribution |
| GS1 | 60667560011000 [Unit of Use] |
| IMD | PACK, HOT OR COLD, DISPOSABLE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-09 |
| Device Publish Date | 2020-09-01 |
| 10667560011036 | Heat Therapy Patches |
| 10667560011005 | Heat Therapy Patches |