FDA UDI
In Commercial Distribution
🇺🇸 United States
Dolphin
DI: 00810055880973
·
Model: DLPH-OOOOOOSWJ-CU
·
JOERNS HEALTHCARE, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Dolphin
- Primary DI
- 00810055880973
- Version / Model
- DLPH-OOOOOOSWJ-CU
- Company Name
- JOERNS HEALTHCARE, LLC
- Labeler DUNS
- 790937150
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-14
- Public Version
- 2
- Public Version Date
- 2024-09-19
- Public Version Status
- Update
- Public Device Record Key
- b0a37ce7-a1a0-4694-8cd5-2f53b49d831a
Device Description
CONTROL UNIT,DOLPHIN,SWISS,JOERNS
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| FNM | Mattress, Air Flotation, Alternating Pressure | General Hospital | 880.5550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36688 | Alternating-pressure inflator | An electrically-powered device that forces ambient air into the parallel chambers of an alternating-pressure bed mattress overlay or an alternating-pressure chair cushion, for the timed alternation of chamber inflation and thereby exchange of patient contact points. The inflator, which may be referred to as a pump and may be programmable, ensures a regular exchange of the overlay/cushion pressure points for the patient. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810055880973 | GS1 |