AccessGUDID - DEVICE: N/A (10190752106529)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: 403751-009
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 403751-009
Company Name: AirLife Finland Oy

Primary DI Number: 10190752106529
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 368457563 *Terms of Use

Device Description: ECG Leadwire, DIN, Radiolucent 5-lead, Grabber, AHA, 150 cm/59 in

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	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?
36038	Radiolucent electrocardiographic lead	A radiolucent insulated metal or non-metallic wire(s) with an electrode used to conduct electrical signals from a patient's heart, via the electrode which is attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine. It is typically used during cardiac catheterization procedures because it will cast a slight or negligible shadow on the radiographic images. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -22 and 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4b797ad1-b020-43bd-a13f-8c7458aa36b2
Public Version Date: October 02, 2025
Public Version Number: 5
DI Record Publish Date: November 23, 2018

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1-833-327-3284
Email: customersupport@vyaire.com

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