AccessGUDID - DEVICE: ENConnect 40 mm Screw Cap to ENPlus Adapter (08056093721072)

GUDID

Device Identifier (DI) Information

Brand Name: ENConnect 40 mm Screw Cap to ENPlus Adapter
Version or Model: A520
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CEDIC SRL

Primary DI Number: 08056093721072
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 429471691 *Terms of Use

Device Description: No description.

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":	Yes
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?
61182	Enteral feeding/medication connector, non-sterile	A non-sterile adaptor intended to enable connection of components of an enteral feeding and/or enteral medication administration kit (e.g., connection between tubing and syringe). It is typically a small plastic device containing a lumen to facilitate enteral administration after connection; it has no additional functionality and is dedicated to enteral administration applications. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
PIO	Enteral Specific Transition Connectors

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190327	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7acc03f0-af8e-4956-aa90-f4ce91d4132a
Public Version Date: June 14, 2019
Public Version Number: 1
DI Record Publish Date: June 06, 2019

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: 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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