AccessGUDID - DEVICE: BoS™ AirShuttle™ (10841962111260)

GUDID

Device Identifier (DI) Information

Brand Name: BoS™ AirShuttle™
Version or Model: RT-5100-04
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RT-5100-04
Company Name: Qfix

Primary DI Number: 10841962111260
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 808875397 *Terms of Use

Device Description: BoS™ AirShuttle™

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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
KPS	System, tomography, computed, emission
JAI	Couch, radiation therapy, powered
LNH	System, nuclear magnetic resonance imaging
LHN	System, radiation therapy, charged-particle, medical
FRZ	DEVICE, PATIENT TRANSFER, POWERED
IYE	Accelerator, linear, medical
JAK	System, x-ray, tomography, computed
OUO	Tomographic imager combining emission computed tomography with nuclear magnetic resonance

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
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Temperature: between 0 and 50 Degrees Celsius
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f96fb0a5-44d5-40a2-ab1e-34849d85d32b
Public Version Date: December 11, 2023
Public Version Number: 3
DI Record Publish Date: September 28, 2021

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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