PDI® Lubricating Jelly II T00137

GUDID 00310819000482

Lubricating jelly to lubricate the body orifices to facilitate the entry of medical and therapeutic devices.

PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.

General-body orifice lubricant, sterile General-body orifice lubricant, sterile General-body orifice lubricant, sterile General-body orifice lubricant, sterile General-body orifice lubricant, sterile General-body orifice lubricant, sterile General-body orifice lubricant, sterile General-body orifice lubricant, sterile General-body orifice lubricant, sterile General-body orifice lubricant, sterile General-body orifice lubricant, sterile General-body orifice lubricant, sterile General-body orifice lubricant, sterile General-body orifice lubricant, sterile General-body orifice lubricant, sterile General-body orifice lubricant, sterile General-body orifice lubricant, sterile General-body orifice lubricant General-body orifice lubricant General-body orifice lubricant General-body orifice lubricant General-body orifice lubricant General-body orifice lubricant General-body orifice lubricant General-body orifice lubricant General-body orifice lubricant General-body orifice lubricant General-body orifice lubricant
Primary Device ID00310819000482
NIH Device Record Keyac1962dc-6cb6-4132-99f0-f4b2bb39bf07
Commercial Distribution StatusIn Commercial Distribution
Brand NamePDI® Lubricating Jelly II
Version Model NumberT00137
Catalog NumberT00137
Company DUNS800777117
Company NamePROFESSIONAL DISPOSABLES INTERNATIONAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com

Device Dimensions

Weight2.7 Gram
Weight2.7 Gram
Weight2.7 Gram
Weight2.7 Gram
Weight2.7 Gram
Weight2.7 Gram
Weight2.7 Gram
Weight2.7 Gram
Weight2.7 Gram
Weight2.7 Gram
Weight2.7 Gram
Weight2.7 Gram
Weight2.7 Gram
Weight2.7 Gram
Weight2.7 Gram
Weight2.7 Gram
Weight2.7 Gram
Weight2.7 Gram
Weight2.7 Gram
Weight2.7 Gram
Weight2.7 Gram
Weight2.7 Gram
Weight2.7 Gram
Weight2.7 Gram
Weight2.7 Gram
Weight2.7 Gram
Weight2.7 Gram
Weight2.7 Gram

Device Identifiers

Device Issuing AgencyDevice ID
GS100310819000482 [Primary]
GS110310819000489 [Package]
Package: Box [144 Units]
In Commercial Distribution

FDA Product Code

KMJLubricant, Patient

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-19
Device Publish Date2020-10-09

On-Brand Devices [PDI® Lubricating Jelly II]

00310819000499Lubricating jelly to lubricate the body orifices to facilitate the entry of medical and therapeu
00310819000482Lubricating jelly to lubricate the body orifices to facilitate the entry of medical and therapeu

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.