AccessGUDID - DEVICE: ENDURE INDUSTRIES (00840118614641)

GUDID

Device Identifier (DI) Information

Brand Name: ENDURE INDUSTRIES
Version or Model: IDPBA8
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IDPBA8
Company Name: ENDURE INDUSTRIES

Primary DI Number: 00840118614641
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 066087031 *Terms of Use

Device Description: Medical ID Bracelets, Pediatric, Blue

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":	Yes
For Single-Use:	Yes
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?
32048	Patient identification band	A single-piece circular band designed to be worn around the wrist (i.e., bracelet, wristband), or sometimes ankle in babies, to provide identification and basic information about a patient. It is typically a slender, thin, and soft plastic band, with a self-locking device, that usually includes printed information with the name, date of birth, patient registration number, and other data that permit clear and easy identification of a patient in the healthcare facility. Some devices also include bar-code information intended for reading with a computerized reader/scanner.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZZ	Marker, Skin

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
Handling Environment Temperature: between 0 and 49 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: be56299e-cbe9-4a94-bbca-45f0458dcf6a
Public Version Date: April 18, 2024
Public Version Number: 1
DI Record Publish Date: April 10, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00840118614658	100	00840118614641		In Commercial Distribution	Box
00840118614665	2000	00840118614641		In Commercial Distribution	Case

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

Customer Contact

[?]

Phone: 6072994971
Email: support@endureind.com

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