FDA UDI
In Commercial Distribution
🇺🇸 United States
Oxygen (O2) Tank Booster Accessory for IVEA
DI: 00850003110110
·
Model: 16289
·
Firefly Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Oxygen (O2) Tank Booster Accessory for IVEA
- Primary DI
- 00850003110110
- Version / Model
- 16289
- Catalog Number
- 16289
- Company Name
- Firefly Medical, Inc.
- Labeler DUNS
- 194670134
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-07
- Public Version
- 2
- Public Version Date
- 2023-10-04
- Public Version Status
- Update
- Public Device Record Key
- ad6eae19-79c6-4cb6-9d7d-dfdb76b3aea5
Device Description
An accessory that attaches to IVEA to allow compatibility and placement of shorter (D size) oxygen tanks on the device
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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| FOX | Stand, Infusion | General Hospital | 880.6990 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42513 | Transportable medical equipment stand, non-powered | A non-powered (non-active) transportable device [e.g., on wheels or easily movable] designed to support medical equipment used for clinical purposes [e.g., in an operating room and/or an examination/treatment room]. It may include manually-adjustable articulated arms to enable dynamic positioning of equipment; the equipment to be supported is not included. The device does not include a battery pack but might include a battery holder and electrical connection wiring to feed power to medical equipment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850003110110 | GS1 |
Customer Contacts
- Phone
- (970) 472-5323
- [email protected]