AccessGUDID - DEVICE: Enable Blood Spot Collection Kit (00860010987803)

GUDID

Device Identifier (DI) Information

Brand Name: Enable Blood Spot Collection Kit
Version or Model: EBCK1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Enable Biosciences Inc.

Primary DI Number: 00860010987803
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079962225 *Terms of Use

Device Description: Sample Collection Kit Dried Blood Spot and Kit Accessories

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):	Yes
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?
65433	Capillary blood collection kit IVD	A collection of in vitro diagnostic devices and materials available for use by a patient/layperson outside a clinical setting to collect and mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a lancet, a blood collection container(s), and a return packing/envelope for mailing to the laboratory. 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: 7e7f7c77-201e-4f39-86cb-ce5b12c2d245
Public Version Date: September 22, 2023
Public Version Number: 1
DI Record Publish Date: September 14, 2023