FDA UDI
In Commercial Distribution
🇺🇸 United States
DISPOSA-HOOD
DI: H67103011
·
Model: Small Hood
·
UTAH MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
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Basic Information
- Brand Name
- DISPOSA-HOOD
- Primary DI
- H67103011
- Version / Model
- Small Hood
- Catalog Number
- 0301
- Company Name
- UTAH MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 094651270
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2020-06-04
- Public Version
- 1
- Public Version Date
- 2020-06-12
- Public Version Status
- New
- Public Device Record Key
- 45f3f828-27a6-4189-9bbf-c773a4e9e2a9
Device Description
SMALL INFANT HOOD, SMALL NECK
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- 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 |
|---|---|---|---|---|
| FOG | Hood, Oxygen, Infant | Anesthesiology | 868.5700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32193 | Oxygen administration hood, paediatric | A device consisting of a rigid/semi-rigid transparent plastic shell that forms an enclosure over an infant's whole body, or the head only, in order to provide an enriched environment of oxygen (O2) 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 to be used for patients adverse to oxygen delivery devices such as a nasal cannula or face mask. This device may include the tubing, a diffuser (to disperse the flow of incoming O2), O2 concentration and humidity sensors. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | H67103011 | HIBCC | ||||
| Unit of Use | H67103010 | HIBCC |
Customer Contacts
- Phone
- 800-533-4984
- [email protected]