FDA.reportPublic FDA data

Sunset Healthcare Durable CPAP Tubing 8 Foot 19mm I.D. with 22mm Cuffs Gray

Primary DI
00848530070212
Brand
Sunset Healthcare Durable CPAP Tubing 8 Foot 19mm I.D. with 22mm Cuffs Gray
Company
Sunset Healthcare Solutions, Inc.
Model
TUB008
Catalog number
TUB008
Device description
Sunset Healthcare Durable CPAP Tubing 8 Foot 19mm I.D. with 22mm Cuffs Gray
Published
2018-09-19
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#

Product Codes#

Code, Name table
CodeName
BZOSet, Tubing And Support, Ventilator (W Harness)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZOSet, Tubing And Support, Ventilator (W Harness)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848530070219PackageGS130In Commercial Distribution
00848530070212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084853007021910848530070219
00848530070212008485300702128485300702120848530070212

GMDN Terms#

Term, Definition table
TermDefinition
Inspiratory/expiratory limb respiratory tubing, reusableA length of tube made of durable materials (e.g., rubber, silicone) intended to be used to conduct breathing gases towards or away from a patient during the respiratory cycle, typically during anaesthesia or ventilation [including continuous or bi-level positive airway pressure ventilation (CPAP or BPAP)]. It is intended to function as part of a breathing circuit and with other separate gas delivery devices (e.g., respiratory mask, connectors). This is a reusable device intended to be cleaned/disinfected prior to use.

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
false
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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00848530109592Ventilator FilterVF010-12026-08-20
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00848530109820Ventilation AccessoryVEN008NS2026-09-09
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