AccessGUDID - DEVICE: WUNDER RS300 PATIENT SCALE BIRDIE EVO XPLUS (05600494138736)

GUDID

Device Identifier (DI) Information

Brand Name: WUNDER RS300 PATIENT SCALE BIRDIE EVO XPLUS
Version or Model: BLS5
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INVACARE CORPORATION

Primary DI Number: 05600494138736
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 076916246 *Terms of Use

Device Description: WUNDER RS300 PATIENT SCALE BIRDIE EVO XPLUS

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):	No
Over the Counter (OTC):	Yes
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?
35996	Patient sling scale	A transportable electronic device designed to lift an immobile patient, typically bedridden, in a sling in order to measure and/or monitor their body weight. It typically consists of a wheeled framework that includes a lifting mechanism (e.g., a hydraulic pump), a patient sling (to encompass the patient's body), a lifting arm, hooks, and an electronic scale (typically incorporating strain gauge transducers). The sling is placed under/around the patient and the lifting arm is used to lift the patient until their whole body is suspended; the scale subsequently displays the measured weight of the patient.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRW	Scale, Patient

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: 8e9a3815-4404-463e-9976-fef44fd7c1d4
Public Version Date: August 23, 2024
Public Version Number: 1
DI Record Publish Date: August 15, 2024