OmniTrustTM 80250-29

GUDID 50810572000040

CPE Isolation Gown, Blue

OMNI INTERNATIONAL CORP.

Isolation gown, single-use
Primary Device ID50810572000040
NIH Device Record Key0059247f-951f-43ab-9c7a-c3a27485f361
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmniTrustTM
Version Model Number80250-29
Catalog Number80250-29
Company DUNS079434709
Company NameOMNI INTERNATIONAL CORP.
Device Count25
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone16034711499
EmailInfo@Omnigloves.com
Phone16034711499
EmailInfo@Omnigloves.com
Phone16034711499
EmailInfo@Omnigloves.com
Phone16034711499
EmailInfo@Omnigloves.com
Phone16034711499
EmailInfo@Omnigloves.com
Phone16034711499
EmailInfo@Omnigloves.com
Phone16034711499
EmailInfo@Omnigloves.com
Phone16034711499
EmailInfo@Omnigloves.com
Phone16034711499
EmailInfo@Omnigloves.com
Phone16034711499
EmailInfo@Omnigloves.com
Phone16034711499
EmailInfo@Omnigloves.com
Phone16034711499
EmailInfo@Omnigloves.com
Phone16034711499
EmailInfo@Omnigloves.com
Phone16034711499
EmailInfo@Omnigloves.com
Phone16034711499
EmailInfo@Omnigloves.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100810572000045 [Primary]
GS110810572000042 [Unit of Use]
GS150810572000040 [Package]
Contains: 00810572000045
Package: Shipper Carton [8 Units]
In Commercial Distribution

FDA Product Code

LYUAccessory, Surgical Apparel

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-24
Device Publish Date2020-12-16

On-Brand Devices [OmniTrustTM]

50810572002143Nitrile Examination Glove Powder Free Medium
50810572000866Vinyl Examination Glove Powder Free Small
50810572006363ABD Combine Dressing, Sterile, 8x10
50810572006585Adhesive Bandages, plastic, 1x3
50810572006578Adhesive Bandages, plastic, 3/4x3
50810572006561Drain Sponge, Sterile, 4x4, 6 ply
50810572006554Non-Adherenet Dressing, Sterile, 3x4
50810572006547Non-Adherenet Dressing, Sterile, 2x3
50810572006523Adhesive Bandages, fabric-Blue Metal Detectable, 1x3
50810572006516Adhesive Bandages, clear, 1x3
50810572006509Adhesive Bandages, clear, 3/4x3
50810572006493Adhesive Bandages, fabric, Patch
50810572006486Adhesive Bandages, fabric, spot
50810572006479Adhesive Bandages, fabric, fingertip
50810572006462Adhesive Bandages, fabric, fingertip
50810572006455Adhesive Bandages, fabric, knuckle
50810572006448Adhesive Bandages, fabric, X-Large
50810572006431Adhesive Bandages, fabric, 1x3
50810572006424Adhesive Bandages, fabric, 3/4x3
50810572006417Adhesive Bandages, sheer, Spot
50810572006400Adhesive Bandages, sheer, X-Large
50810572006394Adhesive Bandages, sheer, junior
50810572006387Adhesive Bandages, sheer, 1x3
50810572006370Adhesive Bandages, sheer, 3/4x3
50810572006356ABD Combine Dressing, Sterile, 8x7.5
50810572006349ABD Combine Dressing, Sterile, 5x9
50810572006332Conforming Elastic Bandage, Sterile 6x75
50810572006325Conforming Elastic Bandage, Sterile 4x75
50810572006318Conforming Elastic Bandage, Sterile 3x75
50810572006301Conforming Elastic Bandage, Sterile 2x75
50810572006295Conforming Elastic Bandage, Non-Sterile 6x75
50810572006288Conforming Elastic Bandage, Non-Sterile 4x75
50810572006271Conforming Elastic Bandage, Non-Sterile 3x75
50810572006264Conforming Elastic Bandage, Non-Sterile 2x75
50810572006257Eye Pad, Sterile
50810572006240Non-Woven Sponge, Sterile, 4x4, 4 Ply
50810572006233Non-Woven Sponge, Sterile, 3x3, 4 Ply
50810572006226Non-Woven Sponge, Sterile, 2x2, 4 Ply
50810572006219Non-Woven Sponge, Non-Sterile, 4x4, 4 Ply
50810572006202Non-Woven Sponge, Non-Sterile, 3x3, 4 Ply
50810572006196Non-Woven Sponge, Non-Sterile, 2x2, 4 Ply
50810572006189Gauze Pads, Sterile, 4x4 12 Ply
50810572006172Gauze Pads, Sterile, 3x3, 12 Ply
50810572006165Gauze Pads, Sterile, 2x2, 12 Ply
50810572006158Gauze Sponge, Sterile, 4x4, 12 ply
50810572006141Gauze Sponge, Sterile, 3x3, 12 ply
50810572006134Gauze Sponge, Sterile, 4x4, 8 ply
50810572006127Gauze Sponge, Sterile, 2x2, 8 Ply
50810572006110Gauze Sponge, Non-Sterile, 4x4, 16 Ply
50810572006103Gauze Sponge, Non-Sterile, 4x4, 8 Ply
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