FDA.report

McKesson

Primary DI
00612479259133
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
59820
Device description
Personal Protection Kit 1 day
Published
2022-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
PXCPersonal Protection Kit

Product Code Classifications

CodeDeviceSpecialtyClass
PXCPersonal Protection KitGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00612479259133PackageGS130In Commercial Distribution
00612479259126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479259133006124792591336124792591330612479259133
00612479259126006124792591266124792591260612479259126

GMDN Terms

TermDefinition
Colour-indication patient thermometerA device designed to measure a patient's skin, oral, rectal, or axillary (armpit) body temperature. The device records body temperature using heat sensitive chemical cells (dots) which are sealed at the end of a plastic or metal strip. Body heat causes a colour change in the heat sensitive chemicals. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
023904428
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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20612479283224McKessonM-8686G2026-05-26
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20612479283385McKessonM-J494G2026-05-26
20612479283392McKessonM-J496G2026-05-26
20612479283408McKessonM-J493G2026-05-26
20612479283415McKessonM-J546G2026-05-26

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