FDA.reportPublic FDA data

Protexter

Primary DI
00813360023400
Brand
Protexter
Company
ICP MEDICAL, LLC
Model
ICP-8150
Catalog number
ICP-8150
Device description
Open Back Gown, SMS, Yellow, Over the Head, Thumb Loop with Elastic Wrist, Universal
Published
2022-11-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10813360023407PackageGS110In Commercial Distribution
20813360023404PackageGS110In Commercial Distribution
00813360023400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081336002340710813360023407
2081336002340420813360023404
00813360023400008133600234008133600234000813360023400

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Regulatory Flags#

DUNS number
078780963
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00688162000665ProtexerPR-Shoe CoversPR-SCGT012026-04-27
00688162000672ProtexerPR-Shoe CoversPR-SCGT022026-04-27
00688162000023ProtexerICP-SCNSICP-SCNS00012025-08-19
00813360021512ProtexerPR-BCBPR-BCB5002025-08-19
00813360021789ProtexerICP-SCNSICP-SCNS00032025-08-19
00813360021796ProtexerICP-SCXTICP-SCXT00022025-08-19
10688162000020ProtexerICP-SCNSICP-SCNS00012025-08-19
10813360021519ProtexerPR-BCBPR-BCB5002025-08-19
10813360021786ProtexerICP-SCNSICP-SCNS00032025-08-19
10813360021793ProtexerICP-SCXTICP-SCXT00022025-08-19
00813360021475ProtexerICP-Lab CoatsICP-9055LC2025-08-15
10813360021472ProtexerICP-Lab CoatsICP-9055LC2025-08-15
00688162000047ProtexerICP-BCNCICP-BCNC00032022-10-31
00688162000511Protexter1ICP-8150FC-2XL2025-08-12
00688162381504ProtexerICP-BCNSICP-BCNS00022022-10-31
10688162000518Protexter1ICP-8150FC-2XL2025-08-12
00688162384512ProtexerICP-CP23ICP-CP232023-06-06
00813360021468ProtexerICP-Lab CoatsICP-9054LC2025-08-08
00688162000030ProtexerICP-ScrubsICP-9000BTM2025-08-08
00688162290004ProtexerICP-ScrubsICP-9000TOP2025-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
40080196772026MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-03
00842942017506PRIMED / CaracalpriMED Medical Products IncOEA2025-11-26
00842942017513PRIMED / CaracalpriMED Medical Products IncOEA2025-11-26
10097604577028Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
10097604577042Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
00842942015700PRIMEDpriMED Medical Products IncOEA2025-07-17
00842942015717PRIMEDpriMED Medical Products IncOEA2025-07-17
00842942017261PRIMEDpriMED Medical Products IncOEA2025-07-17
00842942017278PRIMEDpriMED Medical Products IncOEA2025-07-17
00842942007934PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942008047PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942009570PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942009587PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942014406PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942014420PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942015298PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942015427PRIMEDpriMED Medical Products IncOEA2025-07-15
20885380151511CARDINAL HEALTHCARDINAL HEALTH 200, LLCOEA2025-03-22
10197106720950CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106720974CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106721032CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106721056CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106741979CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-11
10197106472408CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-07
10197106743669CARDINAL HEALTHCardinal Health 200, LLCOEA2024-09-26
10197106743256CARDINAL HEALTHCardinal Health 200, LLCOEA2024-09-20
10097604466407Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2024-09-16
10193489099560MEDLINEMEDLINE INDUSTRIES, INC.OEA2024-07-04
10197106675250CARDINAL HEALTHCardinal Health 200, LLCOEA2024-06-27
10197106665183CARDINAL HEALTHCardinal Health 200, LLCOEA2024-06-25