AccessGUDID - DEVICE: PillCam (07290101360575)

GUDID

Device Identifier (DI) Information

Brand Name: PillCam
Version or Model: FGS-0179
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Covidien LP

Primary DI Number: 07290101360575
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: SB 2 capsule, 1-pack

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	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?
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 [?]
Premarket Submission Number Not Available/Not Released

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 20 and 40 Degrees Celsius
Storage Environment Temperature: between 0 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b6d2157d-6548-433c-8005-3ca94c8ebd70
Public Version Date: March 09, 2023
Public Version Number: 6
DI Record Publish Date: January 31, 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: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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