ICP RR-300XL

GUDID 00813360021482

Isolation gown, single-use

Primary Device ID	00813360021482
NIH Device Record Key	945f2116-8a77-4e53-a620-6e93baaca5b6
Commercial Distribution Status	In Commercial Distribution
Brand Name	ICP
Version Model Number	1
Catalog Number	RR-300XL
Company DUNS	078780963
Company Name	ICP MEDICAL, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00813360021482 [Primary]
GS1	10813360021489 [Package] Package: Bag [10 Units] In Commercial Distribution
GS1	20813360021486 [Package] Contains: 10813360021489 Package: case [10 Units] In Commercial Distribution

FME	Gown, Examination

Steralize Prior To Use	false
Device Is Sterile	false

00813360021499	30 GSM AAMI (Level 3) Poly Coated Thumbloop Gown, With Elastic Wrist
00813360021482	30 GSM AAMI (Level 3) Poly Coated Thumbloop Gown, With Elastic Wrist
10813360021625	Universal Mattress Cover
10813360021632	2XXL White Universal Mattress Cover
00688162000481	Stretcher Sheet, White, SMS 108x51
10688162000464	Stretcher Sheet, White, SMS 96x37