FDA.reportPublic FDA data

ALLEN

Primary DI
00615521030971
Brand
ALLEN
Company
HILL-ROM, INC.
Model
103006
Catalog number
A-70310
Device description
ALLEN COMFORT MASK DISPOSABLE 1 PC.
Published
2023-06-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMEBEDDING, DISPOSABLE, MEDICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00615521002350PackageGS15In Commercial Distribution
00615521030971PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00615521002350006155210023506155210023500615521002350
00615521030971006155210309716155210309710615521030971

GMDN Terms#

Term, Definition table
TermDefinition
Surgical linen/cushion setA collection of devices intended to be fitted to equipment used to support a patient during surgery (e.g., operating table) to provide a hygienic barrier and positioning/support capabilities. It typically includes operating table sheets, covers, pillows/cushions, foam pads, and equipment drapes. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)445-3730us.customerservice@hill-rom.com

Regulatory Flags#

DUNS number
004245668
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00615521014599ALLEN102001F-LHMAQ2023-05-30
00615521031459ALLEN102001F-10056MAQ2023-05-30
00615521031466ALLEN102001F-10057MAQ2023-05-30
00615521012649ALLEN106002F-100152023-05-26
00615521013783ALLEN107002F-ABSLT2023-05-26
00615521014506ALLEN102001F-LH720MAQ2023-05-26
00615521002848ALLEN1030062026-04-24
00615521031008ALLEN1010052026-04-24
00615521031015ALLEN1010052026-04-24
00615521031022ALLEN1020082026-04-24
00615521070007ALLEN1030062026-04-24
00848340016806ALLENA-212002026-04-24
00887761981720Heart and Respiration Rate Monitoring System powered by EarlySenseP2115602021-09-23
00887761985155Heart and Respiration Rate Monitoring System powered by EarlySenseP2008982018-08-22
00887761976870pro+P7924ARENT022026-04-21
00887761007536pro+P3255A072026-04-20
00887761007543pro+P3255A082026-04-20
00887761976863pro+P7924ARENT012026-04-20
00887761976887pro+P3255ARENT012026-04-20
00887761943148WAVE Clinical PlatformDB2026-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16931918186184InvenioGRI Medical & Electronic Technology Co., Ltd.KME2026-04-29
10304040196660Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196677Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196684Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196691Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196707Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196714Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
16931918105475AllesetGRI Medical & Electronic Technology Co., Ltd.KME2026-03-18
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCKME2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCKME2025-11-19
M68959120030Hypothermia Management SetSafeguard US Operating, LLCKME2025-10-24
10304040193157Henry ScheinHENRY SCHEIN, INC.KME2025-09-03
16931918129815HALYARDGRI Medical & Electronic Technology Co., Ltd.KME2025-06-20
10889483602911AirLife™AirLife Finland OyKME2025-04-17
10889483602928AirLife™AirLife Finland OyKME2025-04-17
10889483602935AirLife™AirLife Finland OyKME2025-04-17
10889483602942AirLife™AirLife Finland OyKME2025-04-17
10889483603031AirLife™AirLife Finland OyKME2025-04-17
10889483603048AirLife™AirLife Finland OyKME2025-04-17
10603354120669ComfortTopEHOB INCKME2025-01-22
M68959320040HAWK Advanced Hypothermia Management SetSafeguard US Operating, LLCKME2024-10-08
16931918123400AllesetGRI Medical & Electronic Technology Co., Ltd.KME2024-09-05
16931918177564AllesetGRI Medical & Electronic Technology Co., Ltd.KME2024-09-05
16931918177984AllesetGRI Medical & Electronic Technology Co., Ltd.KME2024-09-05
07613327632835Sage Multi-Position MATSSAGE PRODUCTS, LLCKME2024-08-12
10850053289580SURGYCOSurgyco LLCKME2024-08-09
16931918115214HALYARDGRI Medical & Electronic Technology Co., Ltd.KME2024-06-11
16931918121987HALYARDGRI Medical & Electronic Technology Co., Ltd.KME2024-06-11
16931918129372HALYARDGRI Medical & Electronic Technology Co., Ltd.KME2024-06-11
16931918149158HALYARDGRI Medical & Electronic Technology Co., Ltd.KME2024-06-11