AccessGUDID - DEVICE: ErgoLite (00840348528725)

GUDID

Device Identifier (DI) Information

Brand Name: ErgoLite
Version or Model: LP-EA444V
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LP-EA444V
Company Name: AADCO MEDICAL, INC.

Primary DI Number: 00840348528725
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 153603204 *Terms of Use

Device Description: .35MM ERGOLITE MAGNABACK VEST CUSTOM FIT

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":	No
For Single-Use:	No
Prescription Use (Rx):	No
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?
38355	Radiation shielding apron	A full or half-length apron-like garment intended to shield portions of the body of an individual (i.e., a device operator, patient, or other attending person) from exposure to radiation during medical or dental procedures. Some include attached or detachable collars for neck and thyroid protection. The device typically consists of a fluid resistant outer covering surrounding a thin sheet of lead (Pb) or lead-equivalent material. Those used for neutron attenuation are composed of hydrogenous materials; those used in mixed beta-gamma radiation field may have layers of both hydrogenous and lead-equivalent materials. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EAJ	Apron, Leaded

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: 2ce831ea-6455-4196-9279-9f6f13ee4ebc
Public Version Date: February 01, 2023
Public Version Number: 1
DI Record Publish Date: January 24, 2023

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

Customer Contact

[?]

No Customer Contact currently defined

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