AccessGUDID - DEVICE: Monoject (10884527002979)

GUDID

Device Identifier (DI) Information

Brand Name: Monoject
Version or Model: 8881307006
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8881307006
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884527002979
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Blood Collection Tube,Silicone Coated Tube, Silicone Coated Royal Blue Stopper, No Additive, 7 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?
37563	Non-evacuated blood collection tube IVD, no additive	A non-evacuated glass or plastic tube, sealed with a stopper, containing no additive and intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JKA	Tubes, vials, systems, serum separators, blood collection

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
Storage Environment Temperature: between 32 and 104 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 13 Millimeter
Total Volume: 7 Milliliter
Length: 100 Millimeter

Device Record Status

Public Device Record Key: 16420822-1ff7-4024-b378-ab926f25e0a0
Public Version Date: November 10, 2021
Public Version Number: 6
DI Record Publish Date: September 24, 2016