AccessGUDID - DEVICE: ISOLATOR™ 1.5 mL Microbial Tubes (10811877010958)

GUDID

Device Identifier (DI) Information

Brand Name: ISOLATOR™ 1.5 mL Microbial Tubes
Version or Model: 50C5
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Alere Scarborough, Inc.

Primary DI Number: 10811877010958
Issuing Agency: GS1
Commercial Distribution End Date: September 30, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 154148498 *Terms of Use

Device Description: The ISOLATOR 1.5 mL microbial tube is intended for use in the collection of small volume pediatric blood samples to be used in the isolation of microorganisms.

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?
61165	Blood cell lysis reagent IVD	A substance or reactant intended to be used alone or in combination with other IVDs to disrupt the cell membrane of blood cells [red blood cells (RBCs), white blood cells (WBCs) and/or platelets] to release cytoplasmic contents in preparation for further analysis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LIO	Device, Specimen Collection

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K832246	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: 4d70b86d-5665-45f9-a9aa-e3a427b22c9a
Public Version Date: September 30, 2024
Public Version Number: 3
DI Record Publish Date: October 23, 2020