AccessGUDID - DEVICE: Hemo-Dial (10857940006527)

GUDID

Device Identifier (DI) Information

Brand Name: Hemo-Dial
Version or Model: M87BX
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M87BX
Company Name: EDLAW PHARMACEUTICALS, INC.

Primary DI Number: 10857940006527
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 90
Labeler D-U-N-S® Number*: 029646569 *Terms of Use

Device Description: MAGNESIUM CHLORIDE 8.7 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 0.5 mEq/L INCREASE WHEN ADDED TO 3.78 LITERS (1 GALLON) IN A 45X PROPORTIONING SYSTEM

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?
35849	Haemodialysis concentrate	A product intended to be mixed with water to prepare a solution with an electrolyte composition similar to that of blood (i.e., a dialysate) for the exchange of solutes with blood through a semi-permeable membrane in the dialyser of a haemodialysis system. It is intended to remove metabolic waste from the blood to help maintain physiological blood electrolyte and pH levels. The product typically includes glucose and salts of the following constituents: sodium, potassium, magnesium, calcium, chloride, and anions of weak acids [e.g., bicarbonate (HCO3), acetate, citrate]. It is supplied as a solution or a dry powder. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPO	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K813388	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
Weight: 2.8 Pound

Device Record Status

Public Device Record Key: 25865667-5a3c-4656-b86a-e8eab0d2f511
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016