| Primary Device ID | 00817369022372 |
| NIH Device Record Key | fb16846d-29a9-43a6-b06d-4b3df6fef667 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NormaTec PCD |
| Version Model Number | AL-5C1A |
| Catalog Number | 10701 |
| Company DUNS | 111448069 |
| Company Name | NORMATEC INDUSTRIES LP |
| Device Count | 1 |
| 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 | false |
| Lot Batch | true |
| 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 | true |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817369022372 [Primary] |
| IRP | Massager, Powered Inflatable Tube |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-22 |
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| 00810050286084 - NormaTec | 2024-05-06 Normatec Elite tall leg system is a powered air pressure inflatable tube massager. It is intended to temporarily relieve minor m |
| 00810050281294 - NormaTec | 2023-06-26 |
| 00810050281720 - NormaTec | 2023-06-26 |
| 00810050281768 - NormaTec | 2023-06-26 |
| 00810050281782 - NormaTec | 2023-06-26 |
| 00810050281805 - NormaTec | 2023-06-26 |
| 00810050281829 - NormaTec | 2023-06-26 |