AccessGUDID - DEVICE: TMM-FBTK-FTX (Tactical Medical Module-Field Blood Transfusion Kit-Exercise) (00856767008243)

GUDID

Device Identifier (DI) Information

Brand Name: TMM-FBTK-FTX (Tactical Medical Module-Field Blood Transfusion Kit-Exercise)
Version or Model: 04135
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 04135
Company Name: Altitude Technologies Inc.

Primary DI Number: 00856767008243
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 621904622 *Terms of Use

Device Description: Tactical Medical Module - Field Blood Transfusion Kit - Exercise

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
POQ	Blood Transfusion Kit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 266ad7e3-b7b9-4a7d-af14-5d911fa093a6
Public Version Date: June 13, 2023
Public Version Number: 3
DI Record Publish Date: May 21, 2020