AccessGUDID - DEVICE: DreamStation (00606959022881)

GUDID

Device Identifier (DI) Information

Brand Name: DreamStation
Version or Model: 00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 100630C
Company Name: Respironics, Inc.

Primary DI Number: 00606959022881
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 9999
Device Count: 1
Labeler D-U-N-S® Number*: 080728314 *Terms of Use

Device Description: DreamStation Cellular Modem, Japan

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):	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?
35477	Clinical laboratory information system	A dedicated assembly of devices designed to electronically receive, collect, store, display, output and distribute clinical laboratory information (e.g., transfer of digital images), within or between healthcare facilities, to support the administrative and clinical activities associated with clinical laboratory services and facilities. Some systems will also assist in data management/analysis. The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded, and not directly used to run, steer, or control laboratory analysers or equipment).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OUG	Medical device data system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f05afc4b-ce58-4543-a0ab-36f801dd9fb9
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 13, 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

[?]

Phone: +1(724)744-2500
Email: respironics.service@philips.com

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