FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SAFE SEDATE®
DI: 00612649205021
·
Model: KS2-SSSMALLUNSC
·
King Systems Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SAFE SEDATE®
- Primary DI
- 00612649205021
- Version / Model
- KS2-SSSMALLUNSC
- Catalog Number
- KS2-SSSMALLUNSC
- Company Name
- King Systems Corporation
- Labeler DUNS
- 009299017
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-27
- Public Version
- 2
- Public Version Date
- 2023-07-17
- Public Version Status
- Update
- Public Device Record Key
- 02179e3f-8938-4b5f-ad53-6fb46ab73cc1
- Distribution End Date
- 2023-07-14
Device Description
Note: KS2-SSSMALLUNSC is new part number for KS2 SSSMALLUNSCE. Product did not change.
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 |
|---|---|---|---|---|
| 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 | 00612649176086 | GS1 | 12 | Not in Commercial Distribution | 2023-07-14 | |
| Primary | 00612649205021 | GS1 |
Customer Contacts
- Phone
- +14107686464
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Small |