| Primary Device ID | 00852678007047 |
| NIH Device Record Key | 9e567dea-256f-402d-a322-fbd2c36d1c69 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Perry Sigma Monoplace |
| Version Model Number | Sigma 34 Elite |
| Company DUNS | 616251443 |
| Company Name | PERRY BAROMEDICAL CORPORATION |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 | false |
| Width | 40 Inch |
| Width | 40 Inch |
| Width | 40 Inch |
| Width | 40 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852678007047 [Primary] |
| CBF | Chamber, Hyperbaric |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-03-01 |
| 00852678007115 | HYPERBARIC SYSTEM, SIGMA 40 ELITE WITH UNDERCARRIAGE |
| 00852678007108 | HYPERBARIC SYSTEM, 34" MONOPLACE CHAMBER WITH UNDERCARRIAGE |
| 00852678007092 | HYPERBARIC SYSTEM, 36" MONOPLACE CHAMBER WITH UNDERCARRIAGE |
| 00852678007085 | HYPERBARIC SYSTEM, 40" MONOPLACE CHAMBER WITH UNDERCARRIAGE |
| 00852678007061 | HYPERBARIC SYSTEM, 40" ELITE MONOPLACE CHAMBER |
| 00852678007054 | HYPERBARIC SYSTEM, 36" ELITE MONOPLACE CHAMBER |
| 00852678007047 | HYPERBARIC SYSTEM, 34" ELITE MONOPLACE CHAMBER |
| 00852678007030 | HYPERBARIC SYSTEM, 40" MONOPLACE CHAMBER |
| 00852678007023 | HYPERBARIC SYSTEM, 36" MONOPLACE CHAMBER |
| 00852678007016 | HYPERBARIC SYSTEM, 34" MONOPLACE CHAMBER |