AccessGUDID - DEVICE: VYGON (03660812115865)

GUDID

Device Identifier (DI) Information

Brand Name: VYGON
Version or Model: 5570.13
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5570.13
Company Name: VYGON

Primary DI Number: 03660812115865
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 392994778 *Terms of Use

Device Description: CPAP Boussignac with connection line

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:	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?
61654	In-line CPAP pressure generating chamber	A sterile portable device intended to be integrated between a medical gas supply and a face mask/mouthpiece (not included) to assist noninvasive ventilation (i.e., without an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous patient respiration in respiratory emergency situations and/or respiratory therapy settings. It is typically a small plastic unit intended to be used with a separate flowmeter and manometer to establish a gas pressure proportional to gas flow rate through turbulent gas flow in an internal chamber using accelerating micro-channels (a virtual valve); tubing may be included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYE	Attachment, breathing, positive end expiratory pressure

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K013884	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 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9a982f11-d131-48a4-9a48-eec44e0a67ec
Public Version Date: April 20, 2020
Public Version Number: 2
DI Record Publish Date: January 29, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
33660812115866	5	03660812115865		In Commercial Distribution	Box
53660812115860	12	33660812115866		In Commercial Distribution	Case

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: Yes
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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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