FDA UDI
In Commercial Distribution
🇺🇸 United States
Forward
DI: 00860000925358
·
Model: 4818-32006
·
Synchronis Medical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Forward
- Primary DI
- 00860000925358
- Version / Model
- 4818-32006
- Catalog Number
- 4818-32006
- Company Name
- Synchronis Medical, LLC
- Labeler DUNS
- 080160207
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-13
- Public Version
- 2
- Public Version Date
- 2023-05-17
- Public Version Status
- Update
- Public Device Record Key
- 6bf1627c-9e18-46d1-945f-ffb852c266f1
Device Description
Field Cricothyrotomy Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| OGP | Cricothyrotomy Kit | Anesthesiology | 868.5800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45926 | Cricothyrotomy kit, single-use | A collection of sterile devices designed to perform a cricothyrotomy (an incision through the skin and cricothyroid) providing airway access within seconds allowing for immediate ventilation of the patient and necessary suction procedures. It is used to open a patient's airway in emergency interventions, e.g., accidental blockage to the upper airway tract, and prior to tracheostomy. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00850015884047 | GS1 | 12 | In Commercial Distribution | ||
| Primary | 00860000925358 | GS1 |
Customer Contacts
- Phone
- 855.752.1011
- [email protected]