FDA.report

Centurion

Primary DI
60653160054530
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
RM100
Catalog number
RM100
Device description
FACE TENT SET UP
Published
2022-01-02
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
true

Related Records

Contact Domains

Product Codes

CodeName
CCQNEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)

Product Code Classifications

CodeDeviceSpecialtyClass
CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
60653160054530PackageGS124In Commercial Distribution
00653160054538PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
6065316005453060653160054530
00653160054538006531600545386531600545380653160054538

GMDN Terms

TermDefinition
Nebulizing system delivery set, single-useA collection of flexible tubing, typically non-sterile, and associated items that may include a mask or mouthpiece, a medication chamber, and connectors, used with a nebulizer to deliver an aerosol, usually medicated, to the patient's respiratory system. It is made of synthetic material and is typically a thick-walled, anti-kink tubing to prevent blockage. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(517)546-5400CUSTOMERSERVICE@CENTURIONMP.COM

Regulatory Flags

DUNS number
017246562
Device count
1
DM exempt
true
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00653160388794CenturionSUT12485ASUT12485A2025-07-14

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