AccessGUDID - DEVICE: Phospholin ES w/ Calcium Chloride (10859394006016)

GUDID

Device Identifier (DI) Information

Brand Name: Phospholin ES w/ Calcium Chloride
Version or Model: 21-410
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 21-410
Company Name: R 2 DIAGNOSTICS, INC.

Primary DI Number: 10859394006016
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 956610125 *Terms of Use

Device Description: APTT reagent 5 x 10 ml with 5 Calcium Chloride

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):	No
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?
55982	Activated partial thromboplastin time (APTT) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of the activated partial thromboplastin time (APTT) of a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GGW	Test, Time, Partial Thromboplastin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K033471	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ae9c351f-f3f7-48ca-83e9-9a89bab556bf
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 15, 2016