AccessGUDID - DEVICE: Capillary Blood Specimen Collection Supplemental Pack (G292590)

GUDID

Device Identifier (DI) Information

Brand Name: Capillary Blood Specimen Collection Supplemental Pack
Version or Model: 6
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 59
Company Name: Biodesix, Inc.

Primary DI Number: G292590
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 809047215 *Terms of Use

Device Description: Capillary blood collection kit, professional

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):	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?
65859	Capillary blood collection set, professional	A collection of devices intended to be used by a healthcare professional at the point-of-care to collect a capillary blood sample from a patient for subsequent diagnostic testing or screening purposes. It typically includes a lancet and a blood collection device (consisting of a capillary tube and blood collection tube) and may also include gloves, gauze pads, alcohol pads and dressings. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PQD	Blood Specimen Collection Convenience Kit (Excludes Hiv)

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: 94f4e9f7-1fd2-4125-97ed-8dda8ccbe5c6
Public Version Date: June 09, 2025
Public Version Number: 5
DI Record Publish Date: July 27, 2023