AccessGUDID - DEVICE: HEMOSPHERE (00690103199338)

GUDID

Device Identifier (DI) Information

Brand Name: HEMOSPHERE
Version or Model: HEMDPT1000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HEMDPT1000
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103199338
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: DPT OUT CABLE

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	No
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?
47487	Electrical-only medical device connection cable, reusable	A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QAQ	Adjunctive Predictive Cardiovascular Indicator
DQE	Catheter, Oximeter, Fiber-Optic
DQK	Computer, Diagnostic, Programmable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180881	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
Special Storage Condition, Specify: Store in cool dry place.

Clinically Relevant Size

[?]

Size Type Text
Length: 15.2 Inch

Device Record Status

Public Device Record Key: 97daaf68-265d-484a-ad89-f528c66c0e00
Public Version Date: July 25, 2019
Public Version Number: 1
DI Record Publish Date: July 17, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)822-9637
Email: tech_support@edwards.com

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