AccessGUDID - DEVICE: Cyto-Chex BCT (30844509002209)

GUDID

Device Identifier (DI) Information

Brand Name: Cyto-Chex BCT
Version or Model: 230306
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 230306
Company Name: STRECK, INC.

Primary DI Number: 30844509002209
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 072915986 *Terms of Use

Device Description: A direct-draw blood collection tube for the preservation of whole blood specimens for immunophenotyping by flow cytometry. 4 ml vials.

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?
47588	Evacuated blood collection tube IVD, K3EDTA	A sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and the anticoagulant tripotassium ethylene diamine tetraacetic acid (K3EDTA). It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation [e.g., whole blood haematology such as complete blood count (CBC), and quantitative drug assay determinations]. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GIM	Tubes, Vacuum Sample, With Anticoagulant

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K080552	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 18 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 4.0 Milliliter

Device Record Status

Public Device Record Key: e4ee6b99-3db3-49e9-b418-f239b20b5d1d
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 16, 2016