FDA UDI
In Commercial Distribution
🇺🇸 United States
TMM-FBTK-FTX (Tactical Medical Module-Field Blood Transfusion Kit-Exercise)
DI: 00856767008243
·
Model: 04135
·
Altitude Technologies Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TMM-FBTK-FTX (Tactical Medical Module-Field Blood Transfusion Kit-Exercise)
- Primary DI
- 00856767008243
- Version / Model
- 04135
- Catalog Number
- 04135
- Company Name
- Altitude Technologies Inc.
- Labeler DUNS
- 621904622
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-21
- Public Version
- 3
- Public Version Date
- 2023-06-13
- Public Version Status
- Update
- Public Device Record Key
- 266ad7e3-b7b9-4a7d-af14-5d911fa093a6
Device Description
Tactical Medical Module - Field Blood Transfusion Kit - Exercise
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
- 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 |
|---|---|---|---|---|
| POQ | Blood Transfusion Kit | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38569 | Blood transfusion set, non-exchange | An intravascular administration set intended to be used to administer blood from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device typically includes a needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, a stopcock, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an intravenous (IV) bag or other infusion fluid container. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00856767008243 | GS1 |
Customer Contacts
- Phone
- 800-766-1365
- [email protected]