AccessGUDID - DEVICE: FORWARD IO INFUSION KIT (00850056748018)

GUDID

Device Identifier (DI) Information

Brand Name: FORWARD IO INFUSION KIT
Version or Model: 1011-23000CB
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INTEGRATED MEDCRAFT LLC

Primary DI Number: 00850056748018
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 107523667 *Terms of Use

Device Description: FORWARD IO Infusion Kit with SAM IO Adaptor, SAM IO Driver, SAM IO 25mm Needle Assembly and SAM IO 45mm Assembly.

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
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?
18009	Intraosseous infusion kit	A collection of sterile devices designed to perform an intraosseous (IO) infusion (i.e., an infusion directly into the bone's medullary cavity for the purpose of administering emergency medications and other fluids). It typically consists of a needle (possibly of a special design), an inserting handle, a scalpel, an infusion set, swabs and sutures. This device is used as an alternate to the preferred intravenous (IV) route when this cannot be established in a timely manner, typically during cardiac arrest, patients with respiratory failure or in shock, and when peripheral IV infusion is very difficult. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMI	Needle, Hypodermic, Single Lumen

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191488	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 3ffc51c7-9f06-4af0-b4a7-2359ecc3632f
Public Version Date: September 24, 2024
Public Version Number: 2
DI Record Publish Date: January 23, 2024