AccessGUDID - DEVICE: 75mm Hemato-clad Plain (00860001024005)

GUDID

Device Identifier (DI) Information

Brand Name: 75mm Hemato-clad Plain
Version or Model: 1-000-7500-C
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1-000-7500-C/5
Company Name: DRUMMOND SCIENTIFIC COMPANY

Primary DI Number: 00860001024005
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 002354272 *Terms of Use

Device Description: Capillary Tubes

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:	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?
35770	Capillary blood collection tube IVD, no additive	A glass or plastic collection tube containing no additive, intended to be used for the collection, preservation and/or transport of capillary blood for analysis or other investigation (e.g., microhaematocrit, neonatal bilirubin). It is typically sealed at one or both ends with a putty-like substance following specimen collection. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GHY	HEMATOCRIT, TUBE, RACK, SEALER, HOLDER

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: c79af0fc-ef2f-4f0c-82a7-247e69fc447e
Public Version Date: February 19, 2021
Public Version Number: 2
DI Record Publish Date: May 01, 2019