FDA.report

Medline

Primary DI
20197344012791
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
CTBLANKET522
Catalog number
CTBLANKET522
Device description
CTEMP, BLANKET, UPPER BODY
Published
2024-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DWJSystem, thermal regulating

Product Code Classifications

CodeDeviceSpecialtyClass
DWJSystem, Thermal RegulatingCardiovascular2

Premarket Submissions

SubmissionSupplement
K231211000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K231211000Medline ComfortTemp Patient Warming SystemMedline Industries, LP2023-12-01DWJ

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20197344012791PackageGS110In Commercial Distribution
10197344012794PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019734401279120197344012791
1019734401279410197344012794

GMDN Terms

TermDefinition
External circulating-air core temperature regulation system pad, single-useAn underlay or overlay through which temperature-regulated air is circulated as part of an external circulating-air core temperature regulation system, intended to elevate and/or lower a patient’s core body temperature, typically in surgical and intensive care settings. Air temperature and flow are regulated by a separate control unit (not included). The device is available in a variety of lengths, widths, thicknesses, and shapes to accommodate body size and application (e.g., adult/paediatric, full-/partial-body). This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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