AccessGUDID - DEVICE: Vital Signs™ (10889483590904)

GUDID

Device Identifier (DI) Information

Brand Name: Vital Signs™
Version or Model: 900178-103
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 900178-103
Company Name: AirLife Finland Oy

Primary DI Number: 10889483590904
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 368457563 *Terms of Use
Previous DI: 10190752181298

Device Description: Vital Signs™ Diagnostic Cardiology ECG Connector Set Grabber, IEC, 10/set

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?
60635	Electrocardiographic electrode connector	A small clip designed to enable an electrical connection between an electrocardiographic electrode and an electrocardiographic lead wire. It is typically made of plastic materials, with a metallic part to provide electrical connection, and can be manually applied to a dedicated area of a disk-like electrode that is placed on the patientÃ¢â‚¬â„¢s skin, with a socket at the other end for a plug on the lead. This is a reusable device.	Active	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 [?]
K082851	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
High-level Disinfectant

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -30 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d9b9f6b4-ac8d-4aaa-a79d-13e2712fdba4
Public Version Date: April 10, 2025
Public Version Number: 1
DI Record Publish Date: April 02, 2025