FDA.reportPublic FDA data

Protexer

Primary DI
00688162384512
Brand
Protexer
Company
ICP MEDICAL, LLC
Model
ICP-CP23
Catalog number
ICP-CP23
Device description
"Bouffant Cap, Blue, 23"""
Published
2023-06-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FYFCap, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYFCap, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10688162384519PackageGS1100In Commercial Distribution
20688162384516PackageGS15In Commercial Distribution
00688162384512PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1068816238451910688162384519
2068816238451620688162384516
00688162384512006881623845126881623845120688162384512

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.

Sterilization Methods#

Method table
Method

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
00813360021468ProtexerICP-Lab CoatsICP-9054LC2025-08-08
00688162000030ProtexerICP-ScrubsICP-9000BTM2025-08-08
00688162290004ProtexerICP-ScrubsICP-9000TOP2025-08-08
00688162390506ProtexerICP-ScrubsICP-9050TOP2025-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536901100BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901117BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901124BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901131BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901148BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901155BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901162BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901179BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901186BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
10840330706671ProCureTwin Med, LLCFYF2026-05-05
20197344202215MEDLINEMEDLINE INDUSTRIES, INC.FYF2026-03-16
20680651497271HalyardO&M HALYARD, INC.FYF2025-10-24
TQ26126151701Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.FYF2024-12-09
TQ26126151991Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.FYF2024-12-09
TQ26126152001Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.FYF2024-12-09
10810141933238VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933245VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933252VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933269VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933276VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933283VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933290VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933306VIVIT SupplyVivit Supply LLCFYF2024-11-29
10097604414033Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYF2024-08-12
10097604419014Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYF2024-08-12
10097604455029Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYF2024-08-12
10097604474112Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYF2024-08-12
20197344099945MedlineMEDLINE INDUSTRIES, INC.FYF2024-04-11
20197344036483MedlineMEDLINE INDUSTRIES, INC.FYF2023-12-19
30884389102590MedlineMEDLINE INDUSTRIES, INC.FYF2023-10-13