FDA.reportPublic FDA data

Protexer

Primary DI
00813360021727
Brand
Protexer
Company
ICP MEDICAL, LLC
Model
RR-500
Catalog number
RR-500
Device description
Chemotherapy Gown,AAMI Level 2, ASTM F739 Tested, Purple, Velcro Tab, Knit Cuffs, Purple, Universal
Published
2021-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
OEANon-Surgical Isolation Gown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10813360021724PackageGS110In Commercial Distribution
20813360021721PackageGS150In Commercial Distribution
00813360021727PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081336002172410813360021724
2081336002172120813360021721
00813360021727008133600217278133600217270813360021727

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/examination garment kitA collection of apparel items intended to be worn by healthcare staff during a patient examination or surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. It consists of one or more of the following types of items (which may be worn over a scrub suit): gowns, aprons, shoe covers, sleeve covers, caps, drapes, gloves and surgical face masks. It may in addition include items intended to be worn by the patient to prevent cross-contamination, and hand sanitizing products (e.g., alcohol gel). This is a single-use device.

Regulatory Flags#

DUNS number
078780963
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00688162000764Protexter1ICP-83502026-08-05
00688162000023ProtexerICP-SCNSICP-SCNS00012025-08-19
00688162000047ProtexerICP-BCNCICP-BCNC00032022-10-31
00688162000054ProtexerICP-CPPSB 21"ICP-CPPSB00212022-10-31
00688162000467ICP2ICP-9001GUR2023-10-05
00688162000511Protexter1ICP-8150FC-2XL2025-08-12
00688162000665ProtexerPR-Shoe CoversPR-SCGT012026-04-27
00688162000672ProtexerPR-Shoe CoversPR-SCGT022026-04-27
00688162124002ProtexerICP-CPXP 24ICP-CPXP242022-10-31
00688162381504ProtexerICP-BCNSICP-BCNS00022022-10-31
00688162400007ProtexerICP-CPPSB 24"ICP-CPPSB00242022-10-31
00688162800005ProtexerICP-CPPSB 28"ICP-CPPSB00282022-10-31
00813360021369ProtexerICP-8200ICP-82002022-01-17
00813360021376ProtexerICP-8250ICP-82502022-01-17
00813360021390ProtexerICP-3845ICP-38452022-02-03
00813360021468ProtexerICP-Lab CoatsICP-9054LC2025-08-08
00813360021475ProtexerICP-Lab CoatsICP-9055LC2025-08-15
00813360021505Protexter181502020-07-09
00813360021512ProtexerPR-BCBPR-BCB5002025-08-19
00813360021543ProtexerICP-5050YFCICP-5050YFC2022-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20197344223333MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-10-16
20197344223340MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-10-16
20197344223357MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-10-16
20197344223364MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-10-16
20197344223371MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-10-16
D832CT10L1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT10M1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT10S1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT10XL1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT2L1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT2M1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT2S1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT2XL1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT2XXL1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT6L1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT6M1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT6S1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832CT6XL1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK10L1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK10M1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK10S1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK10XL1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK2L1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK2M1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK2S1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK2XL1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK2XXL1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK6L1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK6M1PlasdentPLASDENT CORPORATIONOEA2026-10-12
D832JK6S1PlasdentPLASDENT CORPORATIONOEA2026-10-12