FDA UDI
In Commercial Distribution
🇺🇸 United States
Resp-O2 Laryngeal Mask Airways Silicone, Reinforced, 1.0 mm
DI: 00840117315464
·
Model: 36285
·
Dynarex Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
5
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Basic Information
- Brand Name
- Resp-O2 Laryngeal Mask Airways Silicone, Reinforced, 1.0 mm
- Primary DI
- 00840117315464
- Version / Model
- 36285
- Company Name
- Dynarex Corporation
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2022-05-23
- Public Version
- 3
- Public Version Date
- 2024-10-09
- Public Version Status
- Update
- Public Device Record Key
- 768fa4e5-d672-4c15-85d7-8e5eb9de007d
Device Description
Sterile-Eo
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 |
|---|---|---|---|---|
| CAE | Airway, Oropharyngeal, Anesthesiology | Anesthesiology | 868.5110 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47803 | Reinforced laryngeal mask airway, single-use | A curved armoured tube with a distal inflatable cuff/mask intended to be used in inhalational anaesthesia and resuscitation to facilitate and secure airway patency for the delivery and exchange of gases in spontaneously breathing and ventilated patients. It is inserted into the hypopharynx above the glottis to create a seal and to prevent the tongue from obstructing the anatomical airway; it is wire reinforced to prevent kinking during patient movement. It may include a 15 mm connector, be radiopaque, and have a built-in pilot balloon for cuff pressure monitoring. It is available in various sizes/designs and is typically made of silicone/plastic materials. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00840117323407 | GS1 | ||||
| Primary | 00840117315464 | GS1 | ||||
| Package | 00840117336025 | GS1 | Shipper | 10 | In Commercial Distribution |