AccessGUDID - DEVICE: Vacuette (19120126130424)

GUDID

Device Identifier (DI) Information

Brand Name: Vacuette
Version or Model: 450085V1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 450085V1
Company Name: Greiner Bio-One GmbH

Primary DI Number: 19120126130424
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 303639066 *Terms of Use

Device Description: SAFETY Blood Collection Set + Holder 21G x 3/4" tubing length 7 1/2" (19 cm), single-packed, sterile, not made with natural rubber latex

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":	Yes
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?
65416	Basic intravenous administration set, invasive	A collection of devices which includes a hypodermic needle (e.g., venous butterfly/scalp vein needle) intended to conduct fluids from an intravenous (IV) fluid container to a patient's venous system during administration; it may also be used for blood collection. In addition to the needle, the set may include tubing, connectors, chambers, clamps, gauze pads, alcohol pads and dressings; a bag/bottle may also be included. 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 [?]
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: 8f39b9eb-cfd0-40e0-ab2a-c8f56560e1bb
Public Version Date: December 15, 2023
Public Version Number: 1
DI Record Publish Date: December 07, 2023