AccessGUDID - DEVICE: Vacuette (19120017577673)

GUDID

Device Identifier (DI) Information

Brand Name: Vacuette
Version or Model: 450097
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 450097
Company Name: Greiner Bio-One GmbH

Primary DI Number: 19120017577673
Issuing Agency: GS1
Commercial Distribution End Date: October 31, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 303639066 *Terms of Use

Device Description: SAFETY Blood Collection Set + HOLDEX® 21G x 3/4" tubing length 12" (30 cm), single-packed, sterile

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):	Yes
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?
58490	Venous butterfly needle/set	An invasive, hollow, tubular, metal device intended to puncture a vein to collect blood and/or for transient (<24 hours) or short-term (<= 30 days) administration of intravenous (IV) fluids. It includes wings for fixation/placement and may include tubing and/or connectors; however, it does not include accessories to facilitate introduction (e.g., stylet). The device may also be referred to as butterfly needle or scalp vein needle. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K011786	000
K080235	000
K121908	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: c2faa28c-5908-49e7-acba-f59cd57fe459
Public Version Date: July 23, 2020
Public Version Number: 5
DI Record Publish Date: September 23, 2016