AccessGUDID - DEVICE: PillCam (07290101364221)

GUDID

Device Identifier (DI) Information

Brand Name: PillCam
Version or Model: RFB-0347
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: RFB-0347
Company Name: Covidien LP

Primary DI Number: 07290101364221
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 058614483 *Terms of Use

Device Description: recorder, DR3 refurbished

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":	No
For Single-Use:	No
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?
41134	Video capsule endoscopy system antenna	An electrically-powered, noninvasive component of a video capsule endoscopy system designed to be attached to/worn by a patient to receive the image data signals from an ingested video capsule and transmit them to the system monitor. It typically has the form of a metallic plate(s) or adhesive pad(s) with connection cables. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NEZ	SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123864	000
K211684	000

Device Exempt from Premarket Submission: No 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 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 44daf097-399c-412e-bef7-87a37c959627
Public Version Date: August 08, 2023
Public Version Number: 9
DI Record Publish Date: February 02, 2017

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

Customer Contact

[?]

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

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