AccessGUDID - DEVICE: Monoject (10884521153387)

GUDID

Device Identifier (DI) Information

Brand Name: Monoject
Version or Model: 8881907199
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8881907199
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884521153387
Issuing Agency: GS1
Commercial Distribution End Date: July 01, 2023
Device Count: 480
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Oral Dose Syringe,Unprinted

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):	No
Over the Counter (OTC):	Yes
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?
59040	ENFit oral/enteral syringe, single-use	A manual device intended to be used for the administration of oral medication or delivery of enteral nutrition by connection to an enteral administration device. It consists of a calibrated hollow barrel (cylinder) and a moveable plunger intended to be operated by a healthcare provider or parent device. The tip is designed to mate only with enteral administration devices (i.e., ENFit) and is incompatible with Luer connectors; the device may be colour-coded to distinguish it from syringes designed to mate with infusion/injection devices. It may include appropriate accessories (e.g., cap, bottle adaptor). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KYW	CONTAINER, LIQUID MEDICATION, GRADUATED

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep dry;AVOID DIRECT SUNLIGHT

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 10 Milliliter

Device Record Status

Public Device Record Key: 903f23ec-0654-48c3-aa59-28c28cb969c8
Public Version Date: July 03, 2023
Public Version Number: 5
DI Record Publish Date: June 27, 2018