AccessGUDID - DEVICE: NeoConnect Syringe Tip Cap (00817584010963)

GUDID

Device Identifier (DI) Information

Brand Name: NeoConnect Syringe Tip Cap
Version or Model: PNM-TCNC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PNM-TCNC
Company Name: NEOMED, INC.

Primary DI Number: 00817584010963
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 799772079 *Terms of Use

Device Description: NeoConnect NeoSecure Tip Cap, Sterile, Purple

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?
16825	Syringe tip cap	A device intended to cover the tip of a syringe (without a needle) in order to prevent the leakage of syringe contents and to maintain content sterility until the syringe is used. This device is typically constructed of plastic. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
PIF	Gastrointestinal Tubes With Enteral Specific Connectors

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e442c6e7-bdc4-41a2-b013-a6babe9e5f54
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 19, 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
20817584010967	16	10817584010960		In Commercial Distribution	Shipper
10817584010960	200	00817584010963		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: 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

[?]

Phone: 886-876-2225
Email: info@neomedinc.com

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