FDA.reportPublic FDA data

PrepEM Wild

Primary DI
06975675781711
Brand
PrepEM Wild
Company
EMSRUN GROUP
Model
Nitrile gloves/L
Published
2025-11-07
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 Gown

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975675781711PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975675781711069756757817116975675781711

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Regulatory Flags#

DUNS number
712452198
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975675784750RESCUE RESSENTIALSPZSB0034/Z-fold2026-09-22
06975675784682Rhino RescueFirst Aid Kit/IFAK/R202026-06-01
06975675788093Rhino RescueFirst Aid Kit/CPIK0284/Red2026-06-01
06975675788109Rhino RescueFirst Aid Kit/CPIK02852026-06-01
06975675788123Rhino RescueFirst aid kit/CPIK0269/Red2026-02-09
16975675788120Rhino RescueFirst aid kit/CPIK0269/Red2026-02-09
06975675781490PrepEM Wild18in splint2025-11-07
06975675781650PrepEM WildWound plaster/15pcs2025-11-07
06975675781667PrepEM WildNon-woven tape/2.5cm*5m2025-11-07
06975675781759PrepEM WildEmergency blanket/1.6*2.1m2025-11-07
06975675781773PrepEM WildScissors/16cm2025-11-07
06975675782091PrepEM WildPBT bandage/7.5cm*4.5m2025-11-07
06975675783074PrepEM WildWound compress/10*10cm/2pcs2025-11-07
06975675783302PrepEM WildCompressed gauze z-fold2025-11-07
06975675788499StBernardFirst aid kit/STIK00082025-11-07
06975675788505StBernardFirst aid kit/STIK00072025-11-07
06975675788512StBernardFirst aid kit/STIK00062025-11-07
06975675788529StBernardFirst aid kit/STIK00052025-11-07
06975675788536StBernardFirst aid kit/STIK00042025-11-07
06975675788543StBernardFirst aid kit/STIK00032025-11-07

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