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
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
06975675788574PrepEM WildAbdominal pad/12.7*23cm2025-11-07
06975675788581PrepEM WildDry burn dressing/40*60cm2025-11-07
06975675788789Rhino RescueFirst aid kit/CPIK0220/20L/Black2025-11-07
06975675788796Rhino RescueChest seal/CPXF0041/20pcs2025-11-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10097604577042Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
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10198956101746CARDINAL HEALTHCardinal Health 200, LLCOEA2025-06-06
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10198956101906CARDINAL HEALTHCardinal Health 200, LLCOEA2025-06-05
10198956089303CARDINAL HEALTHCardinal Health 200, LLCOEA2025-05-22
10197106988251CARDINAL HEALTHCardinal Health 200, LLCOEA2025-05-19
10198956089143CARDINAL HEALTHCardinal Health 200, LLCOEA2025-05-14
10197106988176CARDINAL HEALTHCardinal Health 200, LLCOEA2025-05-13
10197106824832CARDINAL HEALTHCardinal Health 200, LLCOEA2025-01-02
10197106860120CARDINAL HEALTHCardinal Health 200, LLCOEA2025-01-02
10197106873113CARDINAL HEALTHCardinal Health 200, LLCOEA2024-12-18
10197106861936CARDINAL HEALTHCardinal Health 200, LLCOEA2024-12-11
10197106868249CARDINAL HEALTHCardinal Health 200, LLCOEA2024-12-11
10197106779781CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-20
10197106810477CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-20
10197106835029CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-19
10197106835128CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-18
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
10197106746011CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106833490CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106785140CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-13
10197106827802CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-13