| Primary Device ID | 04953170467226 |
| NIH Device Record Key | 94b7c495-c386-4522-8470-30ae66ebeec7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INSUFFLATION TUBE |
| Version Model Number | MAJ-590 |
| Catalog Number | N4451640 |
| Company DUNS | 711789789 |
| Company Name | OLYMPUS MEDICAL SYSTEMS CORP. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 |
| Phone | +1(800)401-1086 |
| xx@xx.xx | |
| Phone | +1(800)401-1086 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04953170467226 [Primary] |
| HIF | Insufflator, Laparoscopic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04953170467226]
Moist Heat or Steam Sterilization;Ethylene Oxide
[04953170467226]
Moist Heat or Steam Sterilization;Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-06 |
| Device Publish Date | 2025-02-26 |
| 04953170467226 - INSUFFLATION TUBE | 2025-03-06 |
| 04953170467226 - INSUFFLATION TUBE | 2025-03-06 |
| 04953170467233 - SUCTION TUBE | 2025-03-06 |
| 84953170463910 - BALLOON3 | 2025-03-05 |
| 84953170463927 - BALLOON3 | 2025-03-05 |
| 84953170463934 - BALLOON | 2025-03-05 |
| 04953170465949 - WATER CONTAINER | 2024-12-03 |
| 04953170465956 - WATER CONTAINER | 2024-12-03 |
| 04953170465963 - ENDOSCOPIC CO2 REGULATION UNIT | 2024-12-03 |