FDA UDI
In Commercial Distribution
🇺🇸 United States
Motion Medical Distributing
DI: 15060498450109
·
Model: 1664
·
Haslam Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Motion Medical Distributing
- Primary DI
- 15060498450109
- Version / Model
- 1664
- Catalog Number
- 1664
- Company Name
- Haslam Medical, Inc.
- Labeler DUNS
- 604208868
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-26
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- c2f6a7da-e378-4e25-bf43-8b2344e489a1
Device Description
#1664 Cricothyrotomy Kit Contents: (1) ET Tube 6.0mm, (1) ChloraPrep Swab, (1) Scalpel #11, (1) Tracheal Dilator, (1) Tracheal Retractor, (2) 4x4 Sponge
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 | 25060498450106 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 15060498450109 | GS1 |