AccessGUDID - DEVICE: Hang&Go HT Basic (M640R99000900001)

GUDID

Device Identifier (DI) Information

Brand Name: Hang&Go HT Basic
Version or Model: 000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: R9900090
Company Name: RAND SPA

Primary DI Number: M640R99000900001
Issuing Agency: HIBCC
Commercial Distribution End Date: July 23, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 655010531 *Terms of Use

Device Description: Kit for hyperthermic perfusion

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":	Yes
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?
47761	Intravascular/intracavitary-circulation hyperthermia system set	A collection of sterile devices used with an intravascular/intracavitary-circulation hyperthermia system for the circulation of blood/fluids, with or without added chemotherapeutic agents, between the patient and the system's extracorporeal circuit during cancer therapy. It typically consists of drains/catheters, tubing, connectors, manual clamps, and hard or soft reservoirs; some types may include in-line filters, an oxygenator, and temperature sensors. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LGZ	Warmer, Thermal, Infusion Fluid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K120026	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
Storage Environment Temperature: between 5 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 55012470-1157-4913-b11d-031fd8e26991
Public Version Date: July 24, 2020
Public Version Number: 5
DI Record Publish Date: January 27, 2017

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

Customer Contact

[?]

No Customer Contact currently defined

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