FDA.report

CPAP Tube with 6" Segments, Blue, 100' Coil 22mm

Primary DI
00848530070410
Brand
CPAP Tube with 6" Segments, Blue, 100' Coil 22mm
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
TUB100-6B
Catalog number
TUB100-6B
Device description
CPAP Tube with 6" Segments, Blue, 100' Coil 22mm
Published
2018-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
BZOSet, Tubing And Support, Ventilator (W Harness)

Product Code Classifications

CodeDeviceSpecialtyClass
BZOSet, Tubing And Support, Ventilator (W Harness)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00848530070410PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530070410008485300704108485300704100848530070410

GMDN Terms

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.

Sterilization Methods

Method

Contacts

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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