OASIS
GUDID 20650862111013
OASIS DRAIN, PEDIATRIC INLINE & CLAMP
ATRIUM MEDICAL CORPORATION
Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container Thoracic suction collection container| Primary Device ID | 20650862111013 |
| NIH Device Record Key | c9437d7a-3acc-4943-8079-09945882f30f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OASIS |
| Version Model Number | 3612-100 |
| Company DUNS | 051798999 |
| Company Name | ATRIUM MEDICAL 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 | 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 44.6 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 44.6 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 44.6 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 44.6 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 44.6 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 44.6 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 44.6 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 44.6 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 44.6 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 44.6 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 44.6 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 44.6 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 44.6 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 44.6 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 44.6 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 44.6 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 44.6 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 44.6 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 44.6 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 44.6 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 44.6 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 44.6 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 44.6 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 44.6 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 44.6 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 44.6 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 44.6 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 44.6 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 44.6 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 44.6 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 44.6 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 44.6 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 44.6 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 44.6 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00650862111019 [Primary] |
| GS1 | 20650862111013 [Package] Contains: 00650862111019 Package: [6 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K043140
FDA Product Code
| KDQ | Bottle, Collection, Vacuum |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-01-10 |
| Device Publish Date | 2015-09-24 |
On-Brand Devices [OASIS]
| 20650862114014 | DRAIN, DRY DUAL TOTAL REC W/AC |
| 20650862113017 | OASIS DRAIN, BRU, IN-LINE, ATS COMPATIBLE |
| 20650862112010 | OASIS DRAIN, DUAL, IN-LINE, ATS COMPATIBLE |
| 20650862111020 | DRAIN, DRY PEDIATRIC |
| 20650862111013 | OASIS DRAIN, PEDIATRIC INLINE & CLAMP |
| 20650862110092 | DRAIN, SINGLE, W/AC, TYVEK |
| 20650862110054 | DRAIN, DRY SINGLE - SFP |
| 20650862110030 | DRAIN, DRY SINGLE W/AC, ATS |
| 20650862110016 | OASIS DRAIN, SINGLE, INLINE & ATS COMPATIBLE |
Trademark Results [OASIS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OASIS 98610582 not registered Live/Pending |
AMERICAN HEALTH SERVICE SALES CORPORATION 2024-06-20 |
 OASIS 98608981 not registered Live/Pending |
AEG International, LLC 2024-06-19 |
 OASIS 98605667 not registered Live/Pending |
JASON RIVER 2024-06-17 |
 OASIS 98605590 not registered Live/Pending |
JASON RIVERS 2024-06-17 |
 OASIS 98559772 not registered Live/Pending |
ePlant, Inc. 2024-05-20 |
 OASIS 98527307 not registered Live/Pending |
Wolf Steel Group Inc. 2024-04-30 |
 OASIS 98507202 not registered Live/Pending |
OASIS SECURITY LTD 2024-04-18 |
 OASIS 98408314 not registered Live/Pending |
GRTHealth Inc. 2024-02-16 |
 OASIS 98393945 not registered Live/Pending |
Millennium Group LLC 2024-02-06 |
 OASIS 98393909 not registered Live/Pending |
Millennium Group LLC 2024-02-06 |
 OASIS 98326144 not registered Live/Pending |
Genesys Aerosystems, Inc. 2023-12-21 |
 OASIS 98272485 not registered Live/Pending |
Roche, Katie M 2023-11-15 |
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