FDA UDI
In Commercial Distribution
🇺🇸 United States
I-GEL® PLUS ANAESTHESIA, SUPRAGLOTTIC AIRWAY, SIZE 5, LARGE ADULT, 90+KG
DI: 05030267165773
·
Model: 8905000
·
Intersurgical Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- I-GEL® PLUS ANAESTHESIA, SUPRAGLOTTIC AIRWAY, SIZE 5, LARGE ADULT, 90+KG
- Primary DI
- 05030267165773
- Version / Model
- 8905000
- Catalog Number
- 8905000
- Company Name
- Intersurgical Incorporated
- Labeler DUNS
- 785952607
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-14
- Public Version
- 1
- Public Version Date
- 2025-04-22
- Public Version Status
- New
- Public Device Record Key
- 6869962c-56a6-497a-9095-2a0cbb23f569
Device Description
I-GEL® PLUS ANAESTHESIA, SUPRAGLOTTIC AIRWAY, SIZE 5, LARGE ADULT, 90+KG
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
- MR Safe
- 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 |
|---|---|---|---|---|
| 45036 | Laryngeal mask airway, single-use | A curved 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 may include a 15 mm connector that attaches to a breathing circuit or manual resuscitator, 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 |
|---|---|---|---|---|---|---|
| Package | 05030267166459 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 05030267165773 | GS1 |