FDA UDI
In Commercial Distribution
🇺🇸 United States
Endure
DI: B531OMTL20
·
Model: OMTL21017
·
ENDURE INDUSTRIES
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Endure
- Primary DI
- B531OMTL20
- Version / Model
- OMTL21017
- Catalog Number
- OMTL2
- Company Name
- ENDURE INDUSTRIES
- Labeler DUNS
- 066087031
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-20
- Public Version
- 3
- Public Version Date
- 2018-05-23
- Public Version Status
- Update
- Public Device Record Key
- ff5a03d4-b46b-4bf8-b501-24b06002d766
Device Description
Oxygen Mask and Tubing, Size Large, Non-Sterile
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| BYG | Mask, Oxygen | Anesthesiology | 868.5580 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35171 | Rebreathing oxygen face mask | A non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver a proportional mixture of air/oxygen (O2) to a patient's airway. It is made of non-conductive, soft, flexible polymers available in a range of sizes, and designed to create an airtight seal against the patient's face. The device may include tubing and various valves and connectors which may allow for connection to a central vacuum system to enable scavenging of residual (waste) anaesthetic gas from a patient in recovery; other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | OMTL22 | HIBCC | Carton | 50 | In Commercial Distribution | |
| Primary | B531OMTL20 | HIBCC |
Customer Contacts
- Phone
- 16072994971
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Mask Size L |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 49 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 49 Degrees Celsius