AccessGUDID - DEVICE: SAM IO Intraosseous Access System (00822045000247)

GUDID

Device Identifier (DI) Information

Brand Name: SAM IO Intraosseous Access System
Version or Model: IO700-EN
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SAM Medical Products

Primary DI Number: 00822045000247
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131084188 *Terms of Use

Device Description: SAM IO - Driver - 1 Pack

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
64650	Intraosseous-access handpiece, infusion, manual	A hand-held, manually-powered device designed to be used with a separate rotary cutting needle (endpiece) to access bone marrow for intraosseous infusion of fluids and medication. It is used as an alternative to intravenous (IV) access typically when IV access is not feasible. This is a reusable 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: 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: 633d611e-6bd2-4494-ba0b-48f3aca8d389
Public Version Date: December 14, 2020
Public Version Number: 2
DI Record Publish Date: February 26, 2020