AccessGUDID - DEVICE: CONVERTORS (50885380003866)

GUDID

Device Identifier (DI) Information

Brand Name: CONVERTORS
Version or Model: 2700N
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 2700N
Company Name: Cardinal Health 200, LLC

Primary DI Number: 50885380003866
Issuing Agency: GS1
Commercial Distribution End Date: September 03, 2022
Device Count: 1800
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: Infant Blanket BNS

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):	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?
58934	Infant blanket, single-use	A piece of fabric material intended to be used to wrap newborns/infants to retain their body heat and/or absorb fluids. Commonly known as a baby blanket, it is available in a variety of fabrics (e.g., wool, cotton, or synthetic materials) and textures (e.g., cellular or smooth). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KME	BEDDING, DISPOSABLE, MEDICAL

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: Yes

Sterilization Method [?]
Ethylene Oxide

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: 09a964a8-66a1-40f6-934b-9ac8a39189bc
Public Version Date: September 05, 2022
Public Version Number: 6
DI Record Publish Date: June 21, 2016