| Primary Device ID | 80726893115800 |
| NIH Device Record Key | 13ff9c37-364b-4251-ae0b-fbda37421167 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | One and FC2 |
| Version Model Number | 110100U-F |
| Company DUNS | 364614362 |
| Company Name | GLOBAL PROTECTION CORP. |
| Device Count | 12 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 6179462800 |
| ccataldo@globalprotection.com | |
| Phone | 6179462800 |
| ccataldo@globalprotection.com | |
| Phone | 6179462800 |
| ccataldo@globalprotection.com | |
| Phone | 6179462800 |
| ccataldo@globalprotection.com | |
| Phone | 6179462800 |
| ccataldo@globalprotection.com | |
| Phone | 6179462800 |
| ccataldo@globalprotection.com | |
| Phone | 6179462800 |
| ccataldo@globalprotection.com | |
| Phone | 6179462800 |
| ccataldo@globalprotection.com | |
| Phone | 6179462800 |
| ccataldo@globalprotection.com | |
| Phone | 6179462800 |
| ccataldo@globalprotection.com | |
| Phone | 6179462800 |
| ccataldo@globalprotection.com | |
| Phone | 6179462800 |
| ccataldo@globalprotection.com | |
| Phone | 6179462800 |
| ccataldo@globalprotection.com | |
| Phone | 6179462800 |
| ccataldo@globalprotection.com | |
| Phone | 6179462800 |
| ccataldo@globalprotection.com | |
| Phone | 6179462800 |
| ccataldo@globalprotection.com | |
| Phone | 6179462800 |
| ccataldo@globalprotection.com |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00726893115804 [Primary] |
| GS1 | 80726893115800 [Unit of Use] |
| MBU | Single-Use Internal Condom |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-12 |
| Device Publish Date | 2023-12-04 |
| 20726893120147 - myONE | 2025-06-20 A lubricated latex condoms |
| 80628011920290 - JEMS | 2025-05-16 Lubricated latex condoms |
| 80726893116074 - Custom Condoms | 2025-05-16 Lubricated latex condoms. List of condoms- Lifestyle large condoms Lifestyle Ultra sensitive Trustex Lubricated Trustex assorted |
| 80726893120095 - ONE | 2025-04-22 One Oasis Lubricant |
| 80726893118191 - ONE Legend | 2025-01-29 One Legend XL- 3 pack (LTS) |
| 80726893118207 - one super sensitive | 2025-01-29 One Super Sensitive 3 pack (LTS) |
| 80726893120071 - LTS Safer Sex Kit | 2025-01-29 LTS Safer Sex Kit |
| 20726893120086 - myONE | 2025-01-29 MyONE Super Wide 64K, 10-count |