FDA UDI
In Commercial Distribution
🇺🇸 United States
Sharn Inc
DI: 00817518020303
·
Model: LMM-280040
·
Sharn Anesthesia
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- Sharn Inc
- Primary DI
- 00817518020303
- Version / Model
- LMM-280040
- Catalog Number
- LMM-280040
- Company Name
- Sharn Anesthesia
- Labeler DUNS
- 107996118
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2018-10-10
- Public Version
- 1
- Public Version Date
- 2018-11-12
- Public Version Status
- New
- Public Device Record Key
- 77ae37ee-6233-4a72-94a3-508ecd388be9
Device Description
ENDOMASK ELITE, SILICONE REUSE LARYNGEAL MASK,SIZE 4, 5/PK
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 35176 | Anaesthesia face mask, reusable | A flexible, form-shaped device designed to be placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper airway. It is made of conductive or non-conductive rubber, polyvinyl chloride (PVC), or other sterilizable materials that produce a soft, flexible cover to create an airtight seal against the patient's face. It typically includes a 22 mm connector (adult) or a 15 mm connector (paediatric), and is available in a range of sizes. It may be stabilized with a headstrap. This device is sometimes used in association with a manual resuscitator. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817518020303 | GS1 | ||||
| Unit of Use | 00817518021720 | GS1 |
Customer Contacts
- Phone
- +1(800)325-3671
- [email protected]