FDA.reportPublic FDA data

MEDLINE

Primary DI
40080196749615
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
CRI5000
Catalog number
CRI5000
Device description
GOWN,POLY,OVRHD,THUMBLOOP,BLUE,REG
Published
2025-06-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMEGown, examination
OEANon-surgical gown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMEGown, ExaminationGeneral Hospital1
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30080196749618PackageGS115In Commercial Distribution
40080196749615PackageGS15In Commercial Distribution
10080196749614PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3008019674961830080196749618
4008019674961540080196749615
1008019674961410080196749614

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
10888277419452MEDLINEMDTZ1068516ABMDTZ1068516AB2016-10-14
00888277719081RexallDG11009803DG110098032026-06-03
10884389106303MEDLINEDYND20323DYND203232021-01-05
10888277656970MEDLINEDYND50221NSDYND50221NS2021-01-02
10888277656987MEDLINEDYND50223NSDYND50223NS2021-01-02
10888277657007MEDLINEDYND50252NSDYND50252NS2021-01-02
10888277658325MEDLINEOR712NSOR712NS2021-01-02
10888277694507MEDLINEDYND50251NSDYND50251NS2021-01-02
10888277694514MEDLINEDYND50253NS1DYND50253NS12021-01-02
10888277725157MEDLINEEQX2377EQX23772023-12-15
10080196000630Teleflex/Hudson RCI540254022016-04-08
10080196003648Teleflex/Hudson RCI2700-2052700-2052016-04-08
10080196986217Teleflex/Hudson RCI540354032016-04-08
10193489078022NAMICH74904487202H749044872022022-02-24
10812564036022MedlineSYN3000SYN30002026-03-11
10812564036077MedlineSYN3004SYN30042026-03-11
10812564036107MedlineSYN3015SYN30152026-03-11
10812564036183MedlineSYN3020SYN30202026-03-11
10812564036190MedlineSYN3025SYN30252026-03-11
10812564036213MedlineSYN3030SYN30302026-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10097604577028Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
10097604577042Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
20885380151511CARDINAL HEALTHCARDINAL HEALTH 200, LLCOEA2025-03-22
10097604573327Tronex International, Inc.TRONEX INTERNATIONAL, INC.FME2024-12-30
10197106472408CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-07
10097604466407Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2024-09-16
10193489099560MEDLINEMEDLINE INDUSTRIES, INC.OEA2024-07-04
10197106650493CARDINAL HEALTHCardinal Health 200, LLCOEA2024-06-10
10197106648605CARDINAL HEALTHCardinal Health 200, LLCOEA2024-05-20
10197106621349CARDINAL HEALTHCardinal Health 200, LLCOEA2024-05-16
10197106636480CARDINAL HEALTHCardinal Health 200, LLCOEA2024-05-16
10197106645918CARDINAL HEALTHCardinal Health 200, LLCOEA2024-05-07
10197106646625CARDINAL HEALTHCardinal Health 200, LLCOEA2024-05-02
10197106627259CARDINAL HEALTHCardinal Health 200, LLCOEA2024-04-17
10197106589380CARDINAL HEALTHCardinal Health 200, LLCOEA2024-04-08
10197106592151CARDINAL HEALTHCardinal Health 200, LLCOEA2024-04-08
10197106613801CARDINAL HEALTHCardinal Health 200, LLCOEA2024-03-26
10197106489062CARDINAL HEALTHCardinal Health 200, LLCOEA2024-03-20
10197106558959CARDINAL HEALTHCardinal Health 200, LLCOEA2024-03-11
10197106597842CARDINAL HEALTHCardinal Health 200, LLCOEA2024-03-06
10197106561904CARDINAL HEALTHCardinal Health 200, LLCOEA2024-02-08
10197106525074CARDINAL HEALTHCardinal Health 200, LLCOEA2024-02-07
10197106549636CARDINAL HEALTHCardinal Health 200, LLCOEA2024-01-30
10197106511336CARDINAL HEALTHCardinal Health 200, LLCOEA2024-01-23
10197106530337CARDINAL HEALTHCardinal Health 200, LLCOEA2024-01-08
10197106530443CARDINAL HEALTHCardinal Health 200, LLCOEA2024-01-08
10197106515006CARDINAL HEALTHCardinal Health 200, LLCOEA2024-01-03
10197106464311CARDINAL HEALTHCardinal Health 200, LLCOEA2023-12-19
10197106517192CARDINAL HEALTHCardinal Health 200, LLCOEA2023-12-19
10097604546727Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2023-12-11