FDA.reportPublic FDA data

PRIMED / Caracal

Primary DI
10842942017510
Brand
PRIMED / Caracal
Company
priMED Medical Products Inc
Model
CPS20662XL
Device description
PRIMED / Caracal Co-Brand Overhead AAMI 2 Isolation Gown, Thumbloop With Elastic Cuff, Yellow, XL
Published
2025-11-26
Public version status
New
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 Gown

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10842942017510PackageGS110In Commercial Distribution
00842942017513PrimaryGS10
90842942017516Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084294201751010842942017510
00842942017513008429420175138429420175130842942017513
9084294201751690842942017516

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in cool, dry, and well ventilated space out of direct sunlight.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
253287569
Device count
10
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842942012952PRIMEDPM1-21402026-05-15
00842942012969PRIMEDPM1-21452026-05-15
00842942012976PRIMEDPM1-21482026-05-15
00842942012983PRIMEDPM1-21542026-05-15
00842942013140PRIMEDPM1-22122026-05-15
00842942013157PRIMEDPM1-22182026-05-15
00842942013164PRIMEDPM1-22362026-05-15
00842942013171PRIMEDPM1-22402026-05-15
00842942013348PRIMEDPM1-23242026-05-15
00842942013355PRIMEDPM1-23302026-05-15
00842942013362PRIMEDPM1-23362026-05-15
00842942013379PRIMEDPM1-23402026-05-15
00842942013386PRIMEDPM1-23452026-05-15
00842942013393PRIMEDPM1-23482026-05-15
00842942013409PRIMEDPM1-23542026-05-15
00842942013416PRIMEDPM1-23722026-05-15
00842942013577PRIMEDPM1-24242026-05-15
00842942013584PRIMEDPM1-24362026-05-15
00842942013591PRIMEDPM1-24402026-05-15
00842942014833PRIMEDPM1-22242026-05-15

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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10198956101425CARDINAL HEALTHCardinal Health 200, LLCOEA2025-06-10
10198956102163CARDINAL HEALTHCardinal Health 200, LLCOEA2025-06-10
10198956099128CARDINAL HEALTHCardinal Health 200, LLCOEA2025-06-06
10198956101746CARDINAL HEALTHCardinal Health 200, LLCOEA2025-06-06
10198956101401CARDINAL HEALTHCardinal Health 200, LLCOEA2025-06-05
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