| Primary Device ID | 00810000318018 |
| NIH Device Record Key | 54253abf-7616-4df3-be00-0d46693ea1e1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Compeed Advanced Blister Care Medium 12p |
| Version Model Number | 00810000318018 |
| Company DUNS | 081160441 |
| Company Name | HRA PHARMA AMERICA, 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | (862) 260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | (862) 260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | (862) 260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | (862) 260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | (862) 260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | (862) 260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | (862) 260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | (862) 260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | (862) 260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | (862) 260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | (862) 260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | (862) 260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | (862) 260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | (862) 260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | (862) 260-9988 |
| b.meeks@HRA-PHARMA.COM | |
| Phone | (862) 260-9988 |
| b.meeks@HRA-PHARMA.COM |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810000318018 [Primary] |
| NAD | Dressing, Wound, Occlusive |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00810000318018]
Ethylene Oxide
[00810000318018]
Ethylene Oxide
[00810000318018]
Ethylene Oxide
[00810000318018]
Ethylene Oxide
[00810000318018]
Ethylene Oxide
[00810000318018]
Ethylene Oxide
[00810000318018]
Ethylene Oxide
[00810000318018]
Ethylene Oxide
[00810000318018]
Ethylene Oxide
[00810000318018]
Ethylene Oxide
[00810000318018]
Ethylene Oxide
[00810000318018]
Ethylene Oxide
[00810000318018]
Ethylene Oxide
[00810000318018]
Ethylene Oxide
[00810000318018]
Ethylene Oxide
[00810000318018]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-04-03 |
| Device Publish Date | 2020-11-17 |
| 00810000318001 | Blister Support Bandage Cushion |
| 00810000318018 | Blister Support Bandage Cushion |