FDA.report

MEDI-VAC

Primary DI
00630140153290
Brand
MEDI-VAC
Company
Cardinal Health 200, LLC
Model
65652-181
Catalog number
65652-181
Device description
Guard II1200cc Dual Roll Stand
Published
2016-09-20
Public version status
Update
Distribution status
Not 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
FOXSTAND, INFUSION

Product Code Classifications

CodeDeviceSpecialtyClass
FOXStand, InfusionGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00630140153290PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00630140153290006301401532906301401532900630140153290

GMDN Terms

TermDefinition
Suction system canister/bottle holderA device used to hold a dedicated collection/specimen canister or bottle that is used within a suction system. This device can be used to mount the canister/bottle(s) to the suction system when it is mobile (on wheels), or to mount the canister/bottle to a medical device service rail system or a wall rail (typically used on the ward). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
1
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
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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