AccessGUDID - DEVICE: Nellcor (20884522042533)

GUDID

Device Identifier (DI) Information

Brand Name: Nellcor
Version or Model: ADH-P/I
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Covidien LP

Primary DI Number: 20884522042533
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 058614483 *Terms of Use

Device Description: Pediatric-Infant Adhesive Sensor Wrap

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):	Yes
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?
34869	Rotation bed, electric	A mains electricity (AC-powered) bed that provides automated rotation of the patient in a circular framework using electric power. It is used for patients with severe fractures and/or spinal cord injuries to provide an essential periodic change (i.e., rotation) of the patient's body position.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGX	Tape and bandage, adhesive

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
Device Size Text, specify: Patient Weight, 3 to 40, KG;

Device Record Status

Public Device Record Key: 842bc1fa-285d-4237-ba59-49b9aeb9a3a8
Public Version Date: June 24, 2025
Public Version Number: 4
DI Record Publish Date: September 26, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
30884522042530	50	10884522042536		In Commercial Distribution	CASE
10884522042536	2	20884522042533		In Commercial Distribution	PACK_OR_INNER_PACK

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 40884522042537 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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(508)261-8000
Email: covidien.udi@covidien.com

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