AccessGUDID - DEVICE: AMC (00849593063913)

GUDID

Device Identifier (DI) Information

Brand Name: AMC
Version or Model: HO-Y171815
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Advantage Medical Electronics, LLC

Primary DI Number: 00849593063913
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080242300 *Terms of Use

Device Description: Y-Adapter, 2 - Tube Datex to Slip-Lock

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:	No
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?
64094	Blood pressure cuff inflation tubing	A length of flexible tube designed to conduct air from an electronic sphygmomanometer inflation pump to a blood pressure cuff to facilitate cuff inflation during measurement of noninvasive blood pressure (NIBP). It typically includes connectors at each end and does not include any electronic components. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DXQ	Blood Pressure Cuff

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: No
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: 58735d30-0e2a-4503-a87d-06729b45d9fe
Public Version Date: February 10, 2023
Public Version Number: 2
DI Record Publish Date: February 28, 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
No Package DIs found

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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 954-345-9800
Email: info@advantagemed.com

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