AccessGUDID - DEVICE: Medline (20888277703725)

GUDID

Device Identifier (DI) Information

Brand Name: Medline
Version or Model: NON66260
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NON66260
Company Name: MEDLINE INDUSTRIES, INC.

Primary DI Number: 20888277703725
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 025460908 *Terms of Use

Device Description: DBD-60ML ENFIT SYRINGE, AMBER

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?
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
PNR	Enteral Syringes with enteral specific connectors

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190502	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
Special Storage Condition, Specify: KEEP DRY. PROTECT FROM FREEZING. AVOID EXCESSIVE HEAT.
Special Storage Condition, Specify: Protect from freezing. Avoid excessive heat. Keep dry.

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 60 Milliliter

Device Record Status

Public Device Record Key: 518a4355-253b-46e5-9c47-95ac600b112f
Public Version Date: October 29, 2021
Public Version Number: 2
DI Record Publish Date: October 15, 2021

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: 10888277703728 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: +1(800)633-5463
Email: service@medline.com

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