FDA.report

Compella™Surface

Primary DI
00887761996809
Brand
Compella™Surface
Company
HILL-ROM, INC.
Model
P642ACAP0010000
Device description
Hospital Bed Surface
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
OSIBariatric bed

Product Code Classifications

CodeDeviceSpecialtyClass
OSIBariatric BedGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00887761996809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00887761996809008877619968098877619968090887761996809

GMDN Terms

TermDefinition
Alternating-pressure bed mattress overlay systemAn assembly of devices consisting of an alternating-pressure bed mattress overlay and a dedicated pump, which also functions as the control unit, designed to actively alternate a bed occupant's bed-contact points, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
004245668
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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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00615521001230ALLEN102001A-10052-R2023-05-26
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