FDA UDI
In Commercial Distribution
🇺🇸 United States
Olympic Vac-Pac
DI: 00382830005371
·
Model: Size 11
·
NATUS MEDICAL INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Olympic Vac-Pac
- Primary DI
- 00382830005371
- Version / Model
- Size 11
- Catalog Number
- 51611
- Company Name
- NATUS MEDICAL INCORPORATED
- Labeler DUNS
- 962519208
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-02
- Public Version
- 1
- Public Version Date
- 2020-01-10
- Public Version Status
- New
- Public Device Record Key
- fcc6b26e-7081-4716-864c-c6e97f4ec875
Device Description
Olympic Vac-Pac Size 11
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CCX | Support, Patient Position | Anesthesiology | 868.6820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35185 | Patient positioning vacuum mattress | A device designed to position and immobilize a patient's full-body typically during therapeutic interventions or patient transportation. The device immobilizes the body by encompassing it and then applying a vacuum. The device is typically an airtight soft pillow case type of covering made of flexible materials, e.g., plastic or rubber. When sealed, this device retains the shape of the body that it encompasses until the vacuum is released. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00382830005371 | GS1 |
Customer Contacts
- Phone
- 1-800-303-0306
- [email protected]