AccessGUDID - DEVICE: CAPIOX® HEMOCONCENTRATOR (04987350738417)

GUDID

Device Identifier (DI) Information

Brand Name: CAPIOX® HEMOCONCENTRATOR
Version or Model: CX*HC11L
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TERUMO CORPORATION

Primary DI Number: 04987350738417
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690543319 *Terms of Use

Device Description: No description.

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?
44602	Haemoconcentrator	A sterile filter intended to be used in the process of haemoconcentration (the concentration of blood elements by water and electrolyte removal) typically during treatment for fluid overload or during cardiac surgery involving extracorporeal circulation. It is typically an ultrafiltration filter contained within a closed cylindrical housing with connectors to an extracorporeal blood circuit and separate connectors for the removal of excess plasma water together with small plasma solutes (e.g., smaller than 50,000 Daltons); the haemoconcentrate is returned to the patient. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System

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: Fragile. This way up. Keep away from sunlight. Keep away from rain.
Handling Environment Temperature: between 1 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Area/Surface Area: 1.1 Square meter

Device Record Status

Public Device Record Key: 34808744-364a-4454-a367-8df3a9cd1ebe
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 15, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
54987350738412	10	04987350738417		In Commercial Distribution

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1-800-521-2818
Email: cvscustomerservice@terumomedical.com

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