AccessGUDID - DEVICE: Plasti Products (10797876110502)

GUDID

Device Identifier (DI) Information

Brand Name: Plasti Products
Version or Model: PlastiPan1050
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PLASTI-PRODUCTS INC

Primary DI Number: 10797876110502
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 153880372 *Terms of Use

Device Description: Urine Specimen Container

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:	Yes
Prescription Use (Rx):	No
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?
34867	Bedpan	A portable device used by a patient or a person with a disability that is confined to his/her bed as a receptacle in which to urinate and/or defecate. It will be removed and emptied by attending staff and sanitized for reuse. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FOB	Bedpan

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: 360fb743-c452-4177-8806-a92e1a128e8e
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: April 15, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
40797876110503	100	10797876110502		In Commercial Distribution	case

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

Customer Contact

[?]

Phone: 1-800-527-5396
Email: kandyo@plastiproducts.com

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