AccessGUDID - DEVICE: NuRoo (00849174080001)

GUDID

Device Identifier (DI) Information

Brand Name: NuRoo
Version or Model: 08000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: BROWNMED, INC.

Primary DI Number: 00849174080001
Issuing Agency: GS1
Commercial Distribution End Date: September 01, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 091999771 *Terms of Use

Device Description: Baby carrier

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:	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?
60521	Neonatal kangaroo care garment	A non-sterile, upper body garment intended to allow a parent to safely carry/support their premature, dysmature, and/or sick infant in a manner which enables skin-to-skin contact between parent and infant (kangaroo care). It typically consists of a wrap/sweater with a variety of straps, and pockets to accommodate ventilation, monitoring, feeding, and warming devices. This is a reusable garment.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HEF	Binder, Breast

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: 25fdcfe8-d3cc-4acd-b215-855172458c25
Public Version Date: September 28, 2020
Public Version Number: 2
DI Record Publish Date: August 13, 2020

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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