FDA.reportPublic FDA data

Hospice Kit

Primary DI
00848530089207
Brand
Hospice Kit
Company
Sunset Healthcare Solutions, Inc.
Model
AMED114HOSPICEKIT
Catalog number
AMED114HOSPICEKIT
Device description
This kit contains: 2 RES023S Suction Canister, 2 TRAA001S Bulb Tip Yankauer - Vented, 1 RES025 Suction Tubing 1/4in x 6ft.
Published
2018-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848530089207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530089207008485300892078485300892070848530089207

GMDN Terms#

Term, Definition table
TermDefinition
Secretion suction kitA collection of items intended for suctioning secretions from a patient; typically included are sterile gloves, a suction catheter, and a container for collecting the secretions. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
877-578-6738customerservice@sunsethcs.com

Regulatory Flags#

DUNS number
141668116
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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