AccessGUDID - DEVICE: EcoVue HV (00851809002029)

GUDID

Device Identifier (DI) Information

Brand Name: EcoVue HV
Version or Model: 380
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 380
Company Name: HR PHARMACEUTICALS INC.

Primary DI Number: 00851809002029
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 828918164 *Terms of Use

Device Description: Sterile Ultrasound Gel High Viscosity

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?
15321	Skin topical coupling gel	A medium designed to be applied to a patient's unbroken skin surface (excludes the eye surface) to provide a coupling between an analytical or therapeutic device (e.g., ultrasound transducer, optical glucose monitoring system, transcutaneous electrical stimulator) and the patient, allowing for the emission and reception of energy/signals (e.g., electrical current, light) that pass through the skin during an examination or treatment. It is in the form of a fluid-like gel that may also assist in moving the parent device smoothly over the skin. It may be used by a healthcare professional in a clinical setting and layperson in the home. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MUI	Media, coupling, ultrasound

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
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 20 Gram

Device Record Status

Public Device Record Key: 00038e6f-f4d8-4ecc-9431-764db08254e9
Public Version Date: September 21, 2023
Public Version Number: 3
DI Record Publish Date: September 21, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
30851809002020	6	10851809002026	In Commercial Distribution	Case
10851809002026	48	00851809002029	In Commercial Distribution	Box
20851809002023	100	80851809002025	In Commercial Distribution	Box
80851809002025	1	00851809002029	In Commercial Distribution	Tyvek Pouch
40851809002027	4	20851809002023	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: +1(717)252-1110 ext: 110
Email: sbenser@hrpharma.com

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