FDA.report

7301 EAGLE1

Primary DI
00817136026947
Brand
7301 EAGLE1
Company
HANS RUDOLPH, INC.
Model
7301
Catalog number
115019
Device description
E1 MASK-HG-ELB SWVL (LARGE)
Published
2022-10-07
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

Product Codes

CodeName
BYGMask, Oxygen

Product Code Classifications

CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817136026947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817136026947008171360269478171360269470817136026947

GMDN Terms

TermDefinition
Rebreathing oxygen face maskA non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver a proportional mixture of air/oxygen (O2) to a patient's airway. It is made of non-conductive, soft, flexible polymers available in a range of sizes, and designed to create an airtight seal against the patient's face. The device may include tubing and various valves and connectors which may allow for connection to a central vacuum system to enable scavenging of residual (waste) anaesthetic gas from a patient in recovery; other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
007131725
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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008171360277087450 RV2 MASK74501138852024-07-15
008171360276855530 3L SYRINGE5530CR20972024-07-02
008171360276615570 3L SYRINGE55701136212023-11-08
008171360276545570 3L SYRINGE55701139272023-08-21
008171360276475570 3L SYRINGE55701139282023-08-17
008171360276307450 RV2 MASK7450CC16022023-08-11
008171360276237000 CONNECTORS7000CC17062023-06-14
008171360267637000 CONNECTORS7000CC20862023-06-13
008171360276167450 RV2 MASK7450CC21002023-04-13
008171360276092700 NRBV2700CR20872023-04-07
008171360270677450 RV2 MASK7450DR1320A2023-04-05
008171360270747450 RV2 MASK7450CC20812023-04-05
008171360270817450 RV2 MASK7450CC20822023-04-05
008171360270987450 RV2 MASK7450CC17432023-04-05
008171360271047450 RV2 MASK7450CC20512023-04-05
008171360271117450 RV2 MASK7450DR1320C2023-04-05
008171360271287450 RV2 MASK7450CC18592023-04-05
008171360271357450 RV2 MASK74502018302023-04-05

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