AccessGUDID - DEVICE: Monoject (10884527006595)

GUDID

Device Identifier (DI) Information

Brand Name: Monoject
Version or Model: 8881310448
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8881310448
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884527006595
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2023
Device Count: 100
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Blood Collection Tube,Silicone Coated Lavender Stopper, EDTA (NA2) 7.5 mg, 5 mL Draw

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?
37566	Blood collection tube holder, single-use	A hand-held cylindrical device 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 into which the blood collection tube is inserted and to which the user attaches a hypodermic blood collection needle (not included); it may include an integrated blood collection tube spike. This device 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
GIM	Tubes, vacuum sample, with anticoagulant

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Special Storage Condition, Specify: Keep dry;Fragile;AVOID DIRECT SUNLIGHT

Clinically Relevant Size

[?]

Size Type Text
Length: 75 Millimeter
Total Volume: 5 Milliliter
Outer Diameter: 13 Millimeter

Device Record Status

Public Device Record Key: 1adf99f3-dff0-46eb-aef6-1d5a44460cde
Public Version Date: June 30, 2023
Public Version Number: 10
DI Record Publish Date: September 24, 2016