AccessGUDID - DEVICE: VYGON (03660812088794)

GUDID

Device Identifier (DI) Information

Brand Name: VYGON
Version or Model: 368.72
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 368.72
Company Name: VYGON

Primary DI Number: 03660812088794
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 392994778 *Terms of Use

Device Description: Adaptor Nutrisafe 2 - ENFit

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?
46115	General-purpose catheter connector, sterile	A small sterile device intended to create a mechanical union between a catheter and an external device (non-dedicated) typically via a Luer connection; it has an intended use profile that is not dedicated to a specific type of catheter (i.e., can be applied to catheters specific to different anatomical sites and body fluids). It may be used to permit catheter insertion and/or manipulation, and/or to facilitate delivery or extraction of substances through the catheter lumen. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FPD	TUBE, FEEDING

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: 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: 533feb6a-712e-4b9b-b760-d65dc0912519
Public Version Date: October 22, 2018
Public Version Number: 5
DI Record Publish Date: September 14, 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
53660812088799	18	33660812088795		In Commercial Distribution
33660812088795	100	03660812088794		In Commercial Distribution

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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