FDA UDI
In Commercial Distribution
🇺🇸 United States
CLEARLITE™ AIR, ANAESTHETIC FACE MASK, SIZE 4, ADULT, GREEN SEAL, 22F
DI: 05030267167135
·
Model: 7394000
·
Intersurgical Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- CLEARLITE™ AIR, ANAESTHETIC FACE MASK, SIZE 4, ADULT, GREEN SEAL, 22F
- Primary DI
- 05030267167135
- Version / Model
- 7394000
- Company Name
- Intersurgical Incorporated
- Labeler DUNS
- 785952607
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-09
- Public Version
- 2
- Public Version Date
- 2025-02-11
- Public Version Status
- Update
- Public Device Record Key
- 0fcb3102-b865-489b-bc8b-4ababba303a8
Device Description
CLEARLITE™ AIR, ANAESTHETIC FACE MASK, SIZE 4, ADULT, GREEN SEAL, 22F
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| BSJ | Mask, Gas, Anesthetic | Anesthesiology | 868.5550 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46232 | Anaesthesia face mask, single-use | 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 single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05030267167142 | GS1 | 35 | In Commercial Distribution | ||
| Primary | 05030267167135 | GS1 |
Customer Contacts
- Phone
- 3154512900
- [email protected]