AccessGUDID - DEVICE: Elation 5™ (00884450383476)

GUDID

Device Identifier (DI) Information

Brand Name: Elation 5™
Version or Model: 00884450383476
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EX6
Company Name: Merit Medical Systems, Inc.

Primary DI Number: 00884450383476
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 184763290 *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":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
45712	Gastrointestinal/biliary dilation balloon catheter, non-medicated	A long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, may be of the fixed-wire or wire-guided type, and is not coated with a drug/pharmaceutical. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNQ	Dilator, esophageal

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Balloon Outer Diameters-5 mm, 6 mm, 7 mm, 8 mm, 9 mm
Device Size Text, specify: Balloon Length-8 cm
Device Size Text, specify: Catheter Length-180 cm
Device Size Text, specify: Catheter Length-180 cm; Balloon Outer Diameters-5 mm, 6 mm, 7 mm, 8 mm, 9 mm; Balloon Length-8 cm; Catheter Length-180 cm
Device Size Text, specify: Balloon Length-8 cm; Balloon Outer Diameters-5 mm, 6 mm, 7 mm, 8 mm, 9 mm; Balloon Length-8 cm; Catheter Length-180 cm

Device Record Status

Public Device Record Key: ee74462a-4fb7-45da-9963-1da53fa30ef3
Public Version Date: April 25, 2025
Public Version Number: 3
DI Record Publish Date: April 29, 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
10884450383473	20	00884450383476		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: 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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