AccessGUDID - DEVICE: MAXBLEND 2 (00817770021100)

GUDID

Device Identifier (DI) Information

Brand Name: MAXBLEND 2
Version or Model: R229P01-011
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MAXTEC, LLC

Primary DI Number: 00817770021100
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 169911828 *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:	No
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?
31283	Anaesthesia/respiratory gas flowmeter tester	A device designed to determine the accuracy of an anaesthesia/respiratory gas flowmeter, or other respiratory equipment, by serving as a standard of gas flow measurement. Different types use different methods to measure the gas flow rate such as the use of a high-precision calibrated tube, or change in pressure caused by gas flow through an orifice. The device may be calibrated to indicate gas flow rate, e.g., when the outflow is open to the atmosphere or against a specific back pressure. It is intended to be used by a healthcare provider (i.e., clinical technician) in a clinical setting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZR	Mixer, Breathing Gases, Anesthesia Inhalation

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: 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: b0ad3eb9-1f1f-4c02-8a3e-a15bf209210e
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 28, 2016

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

Customer Contact

[?]

No Customer Contact currently defined

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