FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Newtowne Hyperbarics
DI: 00865439000249
·
Model: Seal 31
·
TYPHOON WATER WARES LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Newtowne Hyperbarics
- Primary DI
- 00865439000249
- Version / Model
- Seal 31
- Company Name
- TYPHOON WATER WARES LTD
- Labeler DUNS
- 361527229
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-30
- Public Version
- 4
- Public Version Date
- 2019-01-15
- Public Version Status
- Update
- Public Device Record Key
- 40cb640c-7049-4ee2-a08e-c5bac15dba17
- Distribution End Date
- 2019-01-01
Device Description
Seal model, 31" diameter, portable hyperbaric chamber.
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| CBF | Chamber, Hyperbaric | Anesthesiology | 868.5470 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61959 | Hyperbaric chamber, portable | A non-powered, portable device consisting of a large bag intended to contain a patient and to be inflated above ambient atmospheric pressure for the treatment of acute mountain sickness. The bag is inflated using a foot pump or air compressor, the internal pressure being controlled by an inlet/deflation valve; it is not intended to be used with enriched oxygen. The device is typically used by mountain climbers and athletes who train at high elevation. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00865439000249 | GS1 |
Customer Contacts
- Phone
- 410-575-4220
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051759 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 91 | Inch | |
| Outer Diameter | 31 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Away from sources of heat and chemicals.