HCS

GUDID 10810132040419

Isolation Gown, SMS AAMI Level 2, Yellow, X-Large, Elastic Cuff, Tie Waist, Neck Tab Closure, Latex Free

Concordance Healthcare Solutions LLC

Isolation gown, single-use
Primary Device ID10810132040419
NIH Device Record Key909baa17-2922-4e8d-8292-d50095b188e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameHCS
Version Model NumberHCS3004XL
Company DUNS080220245
Company NameConcordance Healthcare Solutions LLC
Device Count10
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 Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810132040412 [Primary]
GS110810132040419 [Package]
Contains: 00810132040412
Package: Case [5 Units]
In Commercial Distribution
GS120810132040416 [Unit of Use]

FDA Product Code

OEANon-Surgical Isolation Gown

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-17
Device Publish Date2023-04-07

On-Brand Devices [HCS]

10810132040174“Preferred Touch” Nitrile Examination Gloves, Chemo Rated, Latex Free, Powder-Free, Non-Ster
10810132040167“Preferred Touch” Nitrile Examination Gloves, Chemo Rated, Latex Free, Powder-Free, Non-Ster
208101320404542-Graduation Plastic Medicine Cup, 1 oz.
10810132040853Professional Stethoscope, Navy, Pre-assembled
10810132040846Professional Stethoscope, Red, Pre-assembled
10810132040839Professional Stethoscope, Black, Pre-assembled
10810132040730Dual Head Stethoscope, Navy, Pre-assembled
10810132040723Dual Head Stethoscope, Red, Pre-assembled
10810132040716Dual Head Stethoscope, Black, Pre-assembled
10810132040709Dual Head Stethoscope, Yellow, Pre-assembled
10810132040693Nurse Stethoscope, Black, Pre-assembled
10810132040686Nurse Stethoscope, Yellow, Pre-assembled
10810132040679Nurse Stethoscope, Navy, Pre-assembled
10810132040662Nurse Stethoscope, Red, Pre-assembled
30810132040642Lubricating Jelly, 5g Foil Pack, Sterile
10810132040631Lap Sponge w/Loop, Sterile, Pre-washed, Latex-Free, X-Ray Detectable
10810132040624O.R. Towel, 100% Cotton, Blue, Single Use, Pre-Washed, Sterile,
10810132040617O.R. Towel, 100% Cotton, Blue, Single Use, Pre-Washed, Sterile, X-Ray Detectable,
10810132040600O.R. Towel, 100% Cotton, Blue, Single Use, Pre-Washed, Sterile,
10810132040549Biodegradable Emesis Bag, Green, with Twist Closure
10810132040532Emesis Bag, w/Twist Closure
10810132040419Isolation Gown, SMS AAMI Level 2, Yellow, X-Large, Elastic Cuff, Tie Waist, Neck Tab Closure, La
1081013204040210” x 13” Absorbent Washcloth
10810132040396Pill Cutter
10810132040389Pill Crusher
10810132040983Ortho Shorts, Single Use, Blue, SMS, Large, Latex Free
10810132040976Ortho Shorts, Single Use, Blue, SMS, Medium, Latex Free
10810132040969Shoe Cover, Blue, SBPP, Non-conductive, Non-Skid, X-Large
10810132040952Coverall, X-Large, White, Economy Single Use Disposable Zipper Front, Open Leg, Latex Free
10810132040884Aneroid Sphygmomanometer, Child, Latex Free
10810132040877Aneroid Sphygmomanometer, Large Adult, Latex Free
10810132040860Aneroid Sphygmomanometer, Adult, Latex Free
10810132040815Coverall, XX-Large, White, Economy Single Use Disposable Zipper Front, Open Leg, Latex Free
10810132040440Preferred Touch Nitrile Examination Gloves, Chemo Rated, Latex Free, Powder-Free, Non-Sterile, L
10810132040433Preferred Touch Nitrile Examination Gloves, Chemo Rated, Latex Free, Powder-Free, Non-Sterile, M
10810132040426Surgical Masks w/Ear Loops, Blue
10810132040044Ortho Shorts, Single Use, Blue, SMS, XX Large, Latex Free
10810132040037Ortho Shorts, Single Use, Blue, SMS, X Large, Latex Free
10810132040020Surgical Masks w/Ear Loops, Yellow
20810132040010Shoe Cover, Blue, SBPP, Non-conductive, Non-Skid, Universal
1081013204000624” Bouffant Cap, Blue, SBPP, Latex Free
10810132041034Aneroid Sphygmomanometer, Thigh, Latex Free
10810132041027Aneroid Sphygmomanometer, Child, Latex Free
10810132041010Aneroid Sphygmomanometer, Large Adult, Latex Free
10810132041003Aneroid Sphygmomanometer, Adult, Latex Free
10810132040945Isolation Gown, SMS AAMI Level 2, Yellow, Large, Elastic Cuff, Tie Waist, Neck Tab Closure, Late
10810132040938Isolation Gown, SMS AAMI Level 1, Yellow, X-Large, Elastic Cuff, Tie Waist, Neck Tab Closure, La
10810132040921Isolation Gown, SMS AAMI Level 1, Yellow, Large, Elastic Cuff, Tie Waist, Neck Tab Closure, Late
10810132040914Gown Cover, SMS AAMI Level 2 Blue, X-Large, Elastic Cuff, Tie Waist, Neck Tab Closure, Latex Fre
10810132040907Cover Gown, SBPP, Yellow, X-Large, Elastic Cuff, Neck and Waist Ties, Latex Free
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