AccessGUDID - DEVICE: Vacuette (19120017577802)

GUDID

Device Identifier (DI) Information

Brand Name: Vacuette
Version or Model: 450239
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 450239
Company Name: Greiner Bio-One GmbH

Primary DI Number: 19120017577802
Issuing Agency: GS1
Commercial Distribution End Date: May 27, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 303639066 *Terms of Use

Device Description: VACUETTE® QUICKSHIELD Complete PLUS 21G x 1 1/2" single-packed, sterile 0.8 x 38 mm

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?
58284	Blood collection tube holder/needle	A sterile, hand-held cylindrical device with a pre-attached needle designed to be used together with an evacuated blood collection tube to draw blood samples from a patient. It is typically a hollow plastic adaptor with a pre-attached blood collection needle at one end and into which the blood collection tube is inserted at the other end; this also facilitates a multiple-tube blood collection via one venipuncture. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMI	Needle, hypodermic, single lumen

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K072320	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 36 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d98ef440-0c77-46c9-9136-e19d59933904
Public Version Date: May 30, 2022
Public Version Number: 4
DI Record Publish Date: September 23, 2016