FDA.report

Medline

Primary DI
00888277678166
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
HCSPUPPY
Catalog number
HCSPUPPY
Device description
COMPRESSOR,NEBULIZER, CHARACTER, PUPPY
Published
2020-10-28
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
false

Related Records

Contact Domains

Product Codes

CodeName
BTICompressor, air, portable

Product Code Classifications

CodeDeviceSpecialtyClass
BTICompressor, Air, PortableAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888277678166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00888277678166008882776781668882776781660888277678166

GMDN Terms

TermDefinition
Nebulizing system delivery set, reusableA collection of non-sterile devices intended to be connected to a nebulizer system gas compressor or medical gas outlet to create/deliver an aerosol, usually medicated, to the patients respiratory system. It typically includes flexible tubing with connectors, a mask or mouthpiece, and a nebulizing medication chamber; pharmaceuticals are not included. This is a single-patient, reusable device.

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
true
Combination product
false
Lot or batch
true
Serial number
true
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

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