AccessGUDID - DEVICE: Monoject (10884527006656)

GUDID

Device Identifier (DI) Information

Brand Name: Monoject
Version or Model: 8881311743
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8881311743
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884527006656
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Blood Collection Tube,Silicone Coated Lavender Stopper, EDTA (K3) 0.10 mL 15.0% Solution, 10 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
GIM	Tubes, vacuum sample, with anticoagulant

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K771052	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
Special Storage Condition, Specify: Keep dry;Fragile;AVOID DIRECT SUNLIGHT

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 10 Milliliter
Outer Diameter: 16 Millimeter
Length: 100 Millimeter

Device Record Status

Public Device Record Key: 53404412-7701-401c-a9d1-8f74442a8ba5
Public Version Date: November 10, 2021
Public Version Number: 7
DI Record Publish Date: September 24, 2016