FDA UDI
In Commercial Distribution
🇺🇸 United States
Amron Oxygen Treatment Hood
DI: 00860010778609
·
Model: 8891-03S
·
Amron International, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Amron Oxygen Treatment Hood
- Primary DI
- 00860010778609
- Version / Model
- 8891-03S
- Company Name
- Amron International, Inc.
- Labeler DUNS
- 086003852
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-10
- Public Version
- 1
- Public Version Date
- 2023-08-18
- Public Version Status
- New
- Public Device Record Key
- 9eeb9501-9660-4c20-88b9-c946798bb290
Device Description
02 VINYL HOOD W/OPTICAL WINDOW, NECK RING ASSEMBLY, STRAPS AND UNTRIMMED SILICONE NECK SEAL
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FOG | Hood, Oxygen, Infant | Anesthesiology | 868.5700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45543 | Oxygen administration hood, adult | A device consisting of a rigid transparent plastic shell forming an enclosure over the head of an adult, typically to provide an enriched oxygen (O2)environment to increase the patient's O2 uptake. It is connected to an O2 source and may be used concurrently with increased humidification and temperature control. It is designed for a variety of situations: 1) for those adverse to oxygen delivery devices such as a nasal cannula or face mask; 2) for use inside hyperbaric chambers; 3) for specific pulmonary testing. It may include the tubing, a diffuser (to disperse the flow of incoming O2), O2 concentration and humidity sensors, and audio listening facilities. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860010778609 | GS1 |
Customer Contacts
- Phone
- 17602086500
- [email protected]