FDA UDI
In Commercial Distribution
🇺🇸 United States
TMM-CR (Tactical Medical Module - Cricothyroidotomy)
DI: 00863970000438
·
Model: 01364
·
Altitude Technologies Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- TMM-CR (Tactical Medical Module - Cricothyroidotomy)
- Primary DI
- 00863970000438
- Version / Model
- 01364
- Company Name
- Altitude Technologies Inc.
- Labeler DUNS
- 621904622
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-15
- Public Version
- 2
- Public Version Date
- 2023-06-13
- Public Version Status
- Update
- Public Device Record Key
- 2541e46d-5c61-411e-b6cd-d165b1f3cbf1
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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 |
|---|---|---|---|---|
| 12732 | Airway needle | A sterile, sharp bevel-edged, hollow tubular metal instrument typically used to pierce the throat through to the trachea to establish airway patency. It is especially used to perform cricothyroidotomy in emergency cases of respiratory obstruction. It is typically used by emergency medical services (EMS). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00863970000438 | GS1 |