AccessGUDID - DEVICE: Iris AirShuttle™ (10841962118733)

GUDID

Device Identifier (DI) Information

Brand Name: Iris AirShuttle™
Version or Model: XT-5100-60
Commercial Distribution Status: In Commercial Distribution
Catalog Number: XT-5100-60
Company Name: Qfix

Primary DI Number: 10841962118733
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 808875397 *Terms of Use

Device Description: Iris AirShuttle™

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
40536	Patient lifting system stretcher	A lifting device used together with a patient lifting system to provide a support for an incapacitated patient or a person with a disability that is being lifted in a lying (horizontal) position for transfer and (re)positioning. It is designed as an elongated framework with a solid or soft surface upon which the person to be lifted is placed and contained during the lifting process.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAK	System, x-ray, tomography, computed
IYE	Accelerator, linear, medical
KPS	System, tomography, computed, emission
JAI	Couch, radiation therapy, powered
LNH	System, nuclear magnetic resonance imaging
FRZ	DEVICE, PATIENT TRANSFER, POWERED
OUO	Tomographic imager combining emission computed tomography with nuclear magnetic resonance
LHN	System, radiation therapy, charged-particle, medical
IZI	System, X-Ray, Angiographic
OWB	Interventional Fluoroscopic X-Ray System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K230312	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
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 50 Degrees Celsius
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d5bdfb62-0b9b-4226-a4bc-f5b3bc93ad4a
Public Version Date: December 11, 2023
Public Version Number: 2
DI Record Publish Date: April 10, 2023

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(610)268-0585
Email: Compliance@qfix.com

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