AccessGUDID - DEVICE: Vacuette (29120017579926)

GUDID

Device Identifier (DI) Information

Brand Name: Vacuette
Version or Model: 454209CA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 454209CA
Company Name: Greiner Bio-One GmbH

Primary DI Number: 29120017579926
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 303639066 *Terms of Use

Device Description: VACUETTE® TUBE 4 ml K2E K2EDTA 13x75 lavender cap-black ring, non-ridged, Canada

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):	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?
43865	Evacuated blood collection tube IVD, K2EDTA	A sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and the anticoagulant dipotassium ethylene diamine tetraacetic acid (K2EDTA). It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation [e.g., blood lead, whole blood haematology such as complete blood count (CBC), molecular diagnostics, and immunohaematology testing (ABO grouping, Rh typing, antibody screening)]. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
PJE	Blood/plasma collection device for DNA testing
JKA	Tubes, vials, systems, serum separators, blood collection

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK030032	000
BK040018	000
K014104	000
K971236	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 4 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d9369b2d-5d73-4179-ba8a-aab4b0d93b7a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016